{"ID":107661,"post_author":"9412100","post_date":"2023-05-16 18:12:21","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"LIMS Selection Guide for Manufacturing Quality Control","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2023-05-16 18:12:21","post_modified_gmt":"2023-05-16 22:12:21","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=107661","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","holland":null,"_ebook_metadata":{"enabled":"on","private":"0","guid":"D559F245-088B-42D0-B640-10DC4033631E","title":"LIMS Selection Guide for Manufacturing Quality Control","subtitle":"First Edition","cover_theme":"nico_8","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_8&subtitle=First+Edition&editor=Shawn+Douglas&title=LIMS+Selection+Guide+for+Manufacturing+Quality+Control&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FBattery_Manufacturing_Lab_50954228316-scaled.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"","items":{"597876f8d548775f68f71303f49964fb_type":"article","597876f8d548775f68f71303f49964fb_title":"A8. LIMSpec in Microsoft Word format","597876f8d548775f68f71303f49964fb_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format","597876f8d548775f68f71303f49964fb_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/LIMSpec in Microsoft Word formatFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\nA8. LIMSpec in Microsoft Word format \nMicrosoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec in Appendix 1, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\nYou can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to File:LIMSpec for Manufacturing-based Labs v1.0.docx, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\nNote that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n\r\n\n\nCitation information for this chapter \nChapter: Appendix 1. Blank LIMSpec template for manufacturing labs\nTitle: LIMS Selection Guide for Manufacturing Quality Control\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: May 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:11.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","597876f8d548775f68f71303f49964fb_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_LIMSpec_in_Microsoft_Word_format rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_LIMSpec_in_Microsoft_Word_format skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/LIMSpec in Microsoft Word format<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"A8._LIMSpec_in_Microsoft_Word_format\">A8. LIMSpec in Microsoft Word format<\/span><\/h2>\n<p>Microsoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec in Appendix 1, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\n<\/p><p>You can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to <a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec_for_Manufacturing-based_Labs_v1.0.docx\" title=\"File:LIMSpec for Manufacturing-based Labs v1.0.docx\" class=\"wiki-link\" data-key=\"7d0267a925f9103d672e1acb3dd56b6d\">File:LIMSpec for Manufacturing-based Labs v1.0.docx<\/a>, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widening the response column.\n<\/p><p>Note that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n<\/p><p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: Appendix 1. Blank LIMSpec template for manufacturing labs\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for Manufacturing Quality Control<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: May 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230516221108\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.060 seconds\nReal time usage: 0.068 seconds\nPreprocessor visited node count: 10\/1000000\nPost\u2010expand include size: 1710\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 22.098 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\n100.00% 22.098 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14198-0!canonical and timestamp 20230516221108 and revision id 52023. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/LIMSpec_in_Microsoft_Word_format<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","597876f8d548775f68f71303f49964fb_images":[],"597876f8d548775f68f71303f49964fb_timestamp":1684275146,"2d050e46992605c76dc92938bd5bfd39_type":"article","2d050e46992605c76dc92938bd5bfd39_title":"A7. Putting those requirements to practical use and caveats","2d050e46992605c76dc92938bd5bfd39_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use","2d050e46992605c76dc92938bd5bfd39_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Putting LIMSpec to UseFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA7. Putting those requirements to practical use and caveats \nThe LIMSpec covered laboratory informatics requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of ASTM E1578-18 Standard Guide for Laboratory Informatics. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your laboratory. \nSoftware developer considerations \nWhat does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic laboratory information management system (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n\nBuyer considerations \nIf you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n\nSoftware vendor selection \nThat said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.[1][2][3][4][5][6][7][8]\n\nHave a clear business case and build your business needs into your laboratory's requirements.\nBe mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.\nAs discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.\nYou'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?\nSchedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.\nA formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.\nConsider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?\nBe sure to consider future needs as you anticipate potential laboratory expansion.\nDon't be afraid to choose a consultant to help you with the vendor selection process.\nCaveats \nFirst, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \nSecond, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n\nReferences \n\n\n\u2191 Pearce, O. (21 June 2016). \"Software Vendor Selection: How to Define Your Requirements\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (23 June 2016). \"Software Vendor Selection: Finding the Right Vendor\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (28 June 2016). \"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations . Retrieved 07 December 2022 .   \n \n\n\u2191 Pearce, O. (5 July 2016). \"Software Vendor Selection: Requesting Proposals & Quotes\". Montrium Blog. Montrium, Inc. https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes . Retrieved 07 December 2022 .   \n \n\n\u2191 Persaud, D. (4 February 2016). \"Business Requirements Gathering for Enterprise Software Selection\". SelectHub Blog. Abuyo, Inc. https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Lichtenberger, A. (23 July 2012). \"Six Steps for a Successful Vendor Selection\". ITIL.org. https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/ . Retrieved 07 December 2022 .   \n \n\n\u2191 Poon, L. (29 May 2015). \"Insider\u2019s Guide to LIMS Selection\". Genologics Blog. GenoLogics Life Sciences Software Inc. https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/ . Retrieved 20 September 2019 .   \n[dead link ] \n\n\u2191 \"How to Select an ELN for Biology R&D\". Benchling, Inc. https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf . Retrieved 07 December 2022 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:10.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","2d050e46992605c76dc92938bd5bfd39_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Putting_LIMSpec_to_Use rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Putting_LIMSpec_to_Use skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Putting LIMSpec to Use<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A7._Putting_those_requirements_to_practical_use_and_caveats\">A7. Putting those requirements to practical use and caveats<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Requirements_Allocation_Sheet.jpg\" class=\"image wiki-link\" data-key=\"750f6faf620baf76955d7ed0f7c86197\"><img alt=\"Requirements Allocation Sheet.jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The LIMSpec covered <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> requirements organized into five broad categories, which are heavily influenced by the functional requirements checklist and Figure 3 of <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. However, the requirements listed prior are all based on not just the ASTM E1578 standard but also a wide variety of other standards, regulations, guidance documents, and standardized procedures (hereon referred to as \"sources\"). That ultimately means a foundational reasoning is provided for each requirement, not necessarily a \"just because I want it\" reasoning. As foundational requirements, this LIMSpec should thus operate as an excellent starting point for building your own software requirements specification or for researching the best laboratory informatics solution for your <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>. \n<\/p><h3><span class=\"mw-headline\" id=\"Software_developer_considerations\">Software developer considerations<\/span><\/h3>\n<p>What does that mean for you? How can you best use this document? If you're a software developer for the laboratory industry, many of the sources referenced in these requirements should already be familiar to you. However, some of them may not be, and you'll probably want to at least familiarize yourself with them. Additionally, if you're developing a generic <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) or some other informatics solution, not tailored to a particular industry, most everything in chapters two, three, five, and six should largely be applicable to what you're doing with your commercial off-the-shelf (COTS) software solution. Definitely review the requirements items listed there and make sure the most important ones are part of your own software requirements specification. If the software solution you're developing is tailored to a particular industry (e.g., clinical or public health, pharmaceutical development, or heavy metals testing), you'll also want to examine chapter four. If you don't see many requirements for your industry listed (see the \"Caveats\" section later), you'll probably have additional research to conduct to see what additional sources will affect how you develop the functional and, particularly, non-functional requirements. \n<\/p>\n<h3><span class=\"mw-headline\" id=\"Buyer_considerations\">Buyer considerations<\/span><\/h3>\n<p>If you're a potential buyer of a laboratory informatics solution, this LIMSpec is also useful to you. Perhaps you know a bit about your laboratory's workflow and a few of the regulations and standards that influence how that workflow is conducted, but you're not entirely informed. Reviewing the five broad categories of requirements may be necessary to help further inform you regarding what's vital in regards to what a laboratory informatics solution should be capable of. Additionally, you can then use these requirements as a base for your laboratory's own requirements list. Using the categories and their subdivisions, you can then add those requirements that are unique to your laboratory and industry that are not sufficiently covered by the LIMSpec requirements. As you review the various options available to you and narrow down your search, your own list of requirements can be used as both as a personal checklist and as a requirements list you hand over to the vendor you query.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"Software_vendor_selection\">Software vendor selection<\/span><\/h4>\n<p>That said, the requirements you hand off to the vendor should be discussed a bit more. Software vendor selection can at times be a tedious yet necessary process, one which requires careful planning and best practices. This topic has been written about by both software developers and end users alike, and their experiences should play a role in how you select a vendor. What follows is bullet-pointed advice as offered by some of those developers and end users.<sup id=\"rdp-ebb-cite_ref-PearceSoftware16_1-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-2_2-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-2-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-3_3-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-3-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PearceSoftware16-4_4-0\" class=\"reference\"><a href=\"#cite_note-PearceSoftware16-4-4\">[4]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PersaudBusiness16_5-0\" class=\"reference\"><a href=\"#cite_note-PersaudBusiness16-5\">[5]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-LichtenbergerSix12_6-0\" class=\"reference\"><a href=\"#cite_note-LichtenbergerSix12-6\">[6]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-PoonInsider15_7-0\" class=\"reference\"><a href=\"#cite_note-PoonInsider15-7\">[7]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BenchlingHowTo_8-0\" class=\"reference\"><a href=\"#cite_note-BenchlingHowTo-8\">[8]<\/a><\/sup>\n<\/p>\n<ul><li>Have a clear business case and build your business needs into your laboratory's requirements.<\/li>\n<li>Be mindful of how detailed you get with your own business-based requirements and what you initially hand off to a vendor. If you're too specific with too many requirements, you may have trouble finding a vendor that matches up. Start with the essentials that involve your laboratory's processes, regulations, integrations, reporting, service needs, etc. As this LIMSpec is foundation-based, you have a good starting point in that regard. You can always get more detailed with requirements as you narrow down vendors.<\/li>\n<li>As discussed briefly in the introduction, you'll need to prioritize your needs somewhere between \"critical\" and \"nice to have.\" The LIMSpec's requirements are largely critical for most purposes and can be marked as such. The requirements you add will have to be prioritized more carefully.<\/li>\n<li>You'll also want to perform some informal third-party information gathering about the vendors. Are reviews of the vendors trustworthy? Have peers had any interactions and success with the vendor? Does the vendor have the ability to scale to meet your needs?<\/li>\n<li>Schedule demonstrations of programs that seem like strong initial candidates. Make sure there is a question and answer session afterwards, and perform a post-demo evaluation.<\/li>\n<li>A formal request for proposal (RFP) may or may not be necessary, depending on the level of information you acquire prior. However, formally requesting pricing and clarification of maintenance and additional service costs is useful. Just don't let price be the only thing that guides you.<\/li>\n<li>Consider some of the intangibles. Does the vendor genuinely seem interested in your business and its needs? Do they communicate well and promptly? Do they seem flexible and able to accommodate a few special case requirements?<\/li>\n<li>Be sure to consider future needs as you anticipate potential laboratory expansion.<\/li>\n<li>Don't be afraid to choose a consultant to help you with the vendor selection process.<\/li><\/ul>\n<h3><span class=\"mw-headline\" id=\"Caveats\">Caveats<\/span><\/h3>\n<p>First, note that this LIMSpec is still an evolving entity. Standards change. Regulations change. Procedures also change with such standards and regulations. That means that as those foundational characteristics shift, this set of requirements will have to also evolve. As such, do your homework and don't take everything you see here as fixed law. If you're responsible for investigating and\/or purchasing a laboratory informatics system, be sure you have at least some familiarity with the primary industry your laboratory serves, and by extension the regulations and standards that affect it. \n<\/p><p>Second, the number of industry-specific applications of laboratory informatics software continues to grow, and with it also the regulations and standards that affect those specialty laboratories. As such, some industry-specific requirements may have been missed for lack of or too expensive public-facing sources. As mentioned with the first caveat, this version of LIMSpec is evolving, and as industry experts and researchers are able to provide additional feedback on this document, it will surely grow with more relevant sources. In other words, don't consider this complete, particularly if you're in a specialized laboratory industry. You may have to add more items based on you industry knowledge and insights.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-PearceSoftware16-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (21 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">\"Software Vendor Selection: How to Define Your Requirements\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-defining-your-requirements<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+How+to+Define+Your+Requirements&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=21+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-defining-your-requirements&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-2-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-2_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (23 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">\"Software Vendor Selection: Finding the Right Vendor\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-finding-the-right-vendor<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Finding+the+Right+Vendor&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=23+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-finding-the-right-vendor&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-3-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-3_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (28 June 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">\"Software Vendor Selection: The Pitfalls and Successes of Vendor Demos\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-conducting-demonstrations<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+The+Pitfalls+and+Successes+of+Vendor+Demos&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=28+June+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-conducting-demonstrations&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PearceSoftware16-4-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PearceSoftware16-4_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Pearce, O. (5 July 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">\"Software Vendor Selection: Requesting Proposals & Quotes\"<\/a>. <i>Montrium Blog<\/i>. Montrium, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes\" target=\"_blank\">https:\/\/blog.montrium.com\/blog\/software-vendor-selection-requesting-proposals-quotes<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Vendor+Selection%3A+Requesting+Proposals+%26+Quotes&rft.atitle=Montrium+Blog&rft.aulast=Pearce%2C+O.&rft.au=Pearce%2C+O.&rft.date=5+July+2016&rft.pub=Montrium%2C+Inc&rft_id=https%3A%2F%2Fblog.montrium.com%2Fblog%2Fsoftware-vendor-selection-requesting-proposals-quotes&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PersaudBusiness16-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PersaudBusiness16_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Persaud, D. (4 February 2016). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">\"Business Requirements Gathering for Enterprise Software Selection\"<\/a>. <i>SelectHub Blog<\/i>. Abuyo, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/\" target=\"_blank\">https:\/\/www.selecthub.com\/miscellaneous\/technology-selection\/business-requirements-gathering-enterprise-software-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Business+Requirements+Gathering+for+Enterprise+Software+Selection&rft.atitle=SelectHub+Blog&rft.aulast=Persaud%2C+D.&rft.au=Persaud%2C+D.&rft.date=4+February+2016&rft.pub=Abuyo%2C+Inc&rft_id=https%3A%2F%2Fwww.selecthub.com%2Fmiscellaneous%2Ftechnology-selection%2Fbusiness-requirements-gathering-enterprise-software-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-LichtenbergerSix12-6\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-LichtenbergerSix12_6-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Lichtenberger, A. (23 July 2012). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">\"Six Steps for a Successful Vendor Selection\"<\/a>. <i>ITIL.org<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/\" target=\"_blank\">https:\/\/blog.itil.org\/2012\/07\/six-steps-for-a-successful-vendor-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Six+Steps+for+a+Successful+Vendor+Selection&rft.atitle=ITIL.org&rft.aulast=Lichtenberger%2C+A.&rft.au=Lichtenberger%2C+A.&rft.date=23+July+2012&rft_id=https%3A%2F%2Fblog.itil.org%2F2012%2F07%2Fsix-steps-for-a-successful-vendor-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-PoonInsider15-7\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-PoonInsider15_7-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Poon, L. (29 May 2015). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">\"Insider\u2019s Guide to LIMS Selection\"<\/a>. <i>Genologics Blog<\/i>. GenoLogics Life Sciences Software Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/\" target=\"_blank\">https:\/\/www.genologics.com\/blog\/insiders-guide-to-lims-selection\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 20 September 2019<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Insider%E2%80%99s+Guide+to+LIMS+Selection&rft.atitle=Genologics+Blog&rft.aulast=Poon%2C+L.&rft.au=Poon%2C+L.&rft.date=29+May+2015&rft.pub=GenoLogics+Life+Sciences+Software+Inc&rft_id=https%3A%2F%2Fwww.genologics.com%2Fblog%2Finsiders-guide-to-lims-selection%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<sup class=\"noprint Inline-Template\"><span style=\"white-space: nowrap;\">[<i><a href=\"https:\/\/en.wikipedia.org\/wiki\/Wikipedia:Link_rot\" class=\"extiw wiki-link\" title=\"wikipedia:Wikipedia:Link rot\" data-key=\"8e73a2ff6f82d88817bdd8ee8b302ab7\"><span title=\" Dead link since December 2022\">dead link<\/span><\/a><\/i>]<\/span><\/sup><\/span>\n<\/li>\n<li id=\"cite_note-BenchlingHowTo-8\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BenchlingHowTo_8-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">\"How to Select an ELN for Biology R&D\"<\/a>. Benchling, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf\" target=\"_blank\">https:\/\/benchling.com\/static\/docs\/resources\/eln-for-biology-rnd.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 07 December 2022<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Select+an+ELN+for+Biology+R%26D&rft.atitle=&rft.pub=Benchling%2C+Inc&rft_id=https%3A%2F%2Fbenchling.com%2Fstatic%2Fdocs%2Fresources%2Feln-for-biology-rnd.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230516221001\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.415 seconds\nReal time usage: 0.597 seconds\nPreprocessor visited node count: 5820\/1000000\nPost\u2010expand include size: 48191\/2097152 bytes\nTemplate argument size: 15752\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 13080\/5000000 bytes\nLua time usage: 0.110\/7 seconds\nLua virtual size: 5349376\/52428800 bytes\nLua estimated memory usage: 0 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 562.508 1 -total\n 96.92% 545.189 1 Template:Reflist\n 57.88% 325.584 1 Template:Dead_link\n 56.65% 318.676 1 Template:Fix\n 47.14% 265.170 1 Template:Category_handler\n 30.32% 170.577 8 Template:Cite_web\n 27.10% 152.417 8 Template:Citation\/core\n 8.17% 45.985 1 Template:Cat_handler\n 6.74% 37.889 7 Template:Date\n 3.06% 17.207 1 Template:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14197-0!canonical and timestamp 20230516221000 and revision id 52022. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Putting_LIMSpec_to_Use<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","2d050e46992605c76dc92938bd5bfd39_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/c\/cf\/Requirements_Allocation_Sheet.jpg"],"2d050e46992605c76dc92938bd5bfd39_timestamp":1684275146,"8dba7922c519f23896ea896ed1a6beab_type":"article","8dba7922c519f23896ea896ed1a6beab_title":"A6. Security and integrity of systems and operations","8dba7922c519f23896ea896ed1a6beab_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations","8dba7922c519f23896ea896ed1a6beab_plaintext":"\n\nBook:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Security and integrity of systems and operationsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n\r\n\n\nA6. Security and integrity of systems and operations \nNote: These categories cover what ASTM E1578-18 largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.\n\n31. Data integrity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 E-17-1\r\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\nWHO Technical Report Series, #996, Annex 5, 9.1\n\n31.1 System functionality should support ALCOA principles.\n\n\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nASTM E1578-18 E-17-2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nA2LA C211 4.13.2.3\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.1 and 4.9.7\r\n\nNIST 800-53, Rev. 5, SI-12\n\n\n31.2 The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n\n\n\n21 CFR Part 1.1152 (d)\r\n\n21 CFR Part 58.190\r\n\n42 CFR Part 93.305\r\n\n42 CFR Part 93.310\r\n\nASTM E1578-18 E-17-3\r\n\nCLSI QMS22 2.2.2.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.3.4.1\r\n\nEPA ERLN Laboratory Requirements 4.8.6\r\n\nEPA ERLN Laboratory Requirements 4.8.9\r\n\nEPA ERLN Laboratory Requirements 4.9.9\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nOECD GLP Principles 10\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\r\n\nUSDA Data and Instrumentation for PDP 8.1.3\r\n\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n\n31.3 The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n\n\n\n7 CFR Part 91.30\r\n\n7 CFR Part 331.17 (c)\r\n\n9 CFR Part 2.35\r\n\n9 CFR Part 121.17 (c)\r\n\n10 CFR Part 20.2103\u201310\r\n\n10 CFR Part 30.34 (g)\r\n\n10 CFR Part 30.51\u20132\r\n\n21 CFR Part 1.1154 (a)\r\n\n21 CFR Part 11.10 (c)\r\n\n21 CFR Part 58.195\r\n\n21 CFR Part 106.100 (n)\r\n\n21 CFR Part 112.164\r\n\n21 CFR Part 114.100 (e)\r\n\n21 CFR Part 117.315\r\n\n21 CFR Part 120.12\r\n\n21 CFR Part 123.9\r\n\n21 CFR Part 129.80 (h)\r\n\n21 CFR Part 211.180\r\n\n21 CFR Part 212.110 (c)\r\n\n21 CFR Part 225.42 (b-8)\r\n\n21 CFR Part 225.58 (c\u2013d)\r\n\n21 CFR Part 225.102\r\n\n21 CFR Part 225.110\r\n\n21 CFR Part 225.158\r\n\n21 CFR Part 225.202\r\n\n21 CFR Part 226.42 (a)\r\n\n21 CFR Part 226.58 (f)\r\n\n21 CFR Part 226.102\r\n\n21 CFR Part 226.115\r\n\n21 CFR Part 312.57\r\n\n21 CFR Part 312.62\r\n\n21 CFR Part 507.208\r\n\n21 CFR Part 606.160 (d)\r\n\n21 CFR Part 812.140 (d)\r\n\n21 CFR Part 820.180 (b)\r\n\n29 CFR Part 1910.120 (f)(8)\r\n\n29 CFR Part 1910.1030 (h-2)\r\n\n40 CFR Part 141.33\r\n\n40 CFR Part 141.722\r\n\n40 CFR Part 262.11 (f)\r\n\n40 CFR Part 262.40\r\n\n40 CFR Part 262.213\r\n\n40 CFR Part 704 Subpart A\r\n\n40 CFR Part 717.15 (d)\r\n\n42 CFR Part 73.17 (c)\r\n\n42 CFR Part 93.313 (h)\r\n\n42 CFR Part 93.317\r\n\n42 CFR Part 493.1105\r\n\n42 CFR Part 493.1283\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164.316\r\n\n45 CFR Part 164.530\r\n\n61 FR 38806, 9 CFR Part 310.25\r\n\n61 FR 38806, 9 CFR Part 381.94\r\n\n61 FR 38806, 9 CFR Part 417.5\r\n\nA2LA C223 5.4\r\n\nA2LA C223 5.9\r\n\nAAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.2.1\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.3.2\r\n\nABFT Accreditation Manual Sec. E-33\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.5\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.6\r\n\nACMG Technical Standards for Clinical Genetics Laboratories E2.1\r\n\nAIHA-LAP Policies 2022 2A.7.5.1\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7\r\n\nASTM E1578-18 E-17-4\r\n\nBRC GSFS, Issue 8, 3.3.2\r\n\nCAP Laboratory Accreditation Manual\r\n\nCDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition\r\n\nCJIS Security Policy 5.3.4\r\n\nCJIS Security Policy 5.4.6\u20137\r\n\nCJIS Security Policy 5.5.2.1\r\n\nCLSI QMS22 2.8.3\r\n\nCodex Alimentarius CXC 1-1969, Ch.1, 7.4\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.1\r\n\nE.U. Commission Directive 2003\/94\/EC Article 11.4\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d\r\n\nE.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c\r\n\nEPA 815-R-05-004 Chap. III, Sec. 15\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8\r\n\nEPA ERLN Laboratory Requirements 4.9.18\r\n\nEPA ERLN Laboratory Requirements 4.11.17\r\n\nEPA QA\/G-5 2.1.9\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2\r\n\nGFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3\r\n\nICH GCP 4.9.5\r\n\nIFS Food 7, Part 2, 2.1.2.2\r\n\nIFS PACsecure 2, Part 2, 2.1.2.2\r\n\nISO 15189:2012 4.3\r\n\nISO\/IEC 17025:2017 8.4.2\r\n\nNIST 800-53, Rev. 5, AT-4\r\n\nNIST 800-53, Rev. 5, AU-11 and AU-11(1)\r\n\nNIST 800-53, Rev. 5, SI-12\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 10\r\n\nOSHA 1910.1020(d)(1)(i\u2013ii)\r\n\nOSHA 1910.1450(j)(2)\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)\r\n\nSafe Food for Canadians Regulations SOR\/2018-108 Part 5, 90\r\n\nSQF FSC 9, Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3\r\n\nSQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3\r\n\nTNI EL-V1-2016-Rev.2.1 (throughout)\r\n\nUSDA Administrative Procedures for the PDP 5.4\r\n\nUSDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2\r\n\nUSDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c\r\n\nUSDA Sampling Procedures for PDP 6.5\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0\r\n\nWHO Technical Report Series, #986, Annex 2, 15.8\u20139\r\n\nWHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1\n\n\n31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n\n\nASTM E1578-18 E-17-6\r\nCJIS Security Policy 5.4.4\r\nNIST 800-53, Rev. 5, AU-8\r\nWHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1\n\n31.5 The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n\n\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 E-17-7\r\nCJIS Security Policy 5.6.1\n\n31.6 The system shall require each and every user to be assigned a unique user ID.\n\n\n\nASTM E1578-18 E-17-8\r\n\n21 CFR Part 11.10 (e)\r\n\nCJIS Security Policy 5.4.5\r\n\nE.U. Annex 11-9\r\n\nNIST 800-53, Rev. 5, AU-9\n\n\n31.7 The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n\n\nCJIS Security Policy 5.4.2\r\nNIST 800-53, Rev. 5, AU-5\r\nNIST 800-53, Rev. 5, SI-4\n\n31.8 The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n\n\n\n32. Configuration management \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-1-1\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.1 The system shall provide tools to enter and manage user-configurable lookup or master data.\n\n\nASTM E1578-18 S-1-2\n\n32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n\n\n45 CFR Part 162.1002\r\nUSDA Sampling Procedures for PDP 6.3.2\n\n32.3 The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n\n\nASTM E1578-18 S-1-3\n\n32.4 The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n\n\nASTM E1578-18 S-1-4\n\n32.5 The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n\n\n21 CFR Part 211.100 (b)\r\n21 CFR Part 211.160 (a)\n\n32.6 The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n\n\n\n40 CFR Part 3.10\r\n\n40 CFR Part 3.2000\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C13.3\r\n\nASTM E1578-18 S-1-5\r\n\nNIST 800-53, Rev. 5, AU-10\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.7 The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n\n\nASTM E1578-18 S-1-6\n\n32.8 The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n\n\nASTM E1578-18 S-1-7\n\n32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n\n\nASTM E1578-18 S-1-8\n\n32.10 The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n\n\n21 CFR Part 211.68\r\nAPHL 2019 LIS Project Management Guidebook\r\nASTM E1578-18 S-1-9\n\n32.11 The system should allow authorized personnel to perform revision control of lookup or master data.\n\n\nASTM E1578-18 S-1-10\r\nAPHL 2019 LIS Project Management Guidebook\n\n32.12 The system should provide a means for importing lookup or master data.\n\n\n\nAIHA-LAP Policies 2022 2A.7.8.4\r\n\nASTM E1578-18 S-1-11\r\n\nEPA ERLN Laboratory Requirements 4.11.6\r\n\nUSDA Data and Instrumentation for PDP 9.1\n\n\n32.13 The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n\n\nASTM E1578-18 S-1-12\n\n32.14 The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n\n\nASTM E1578-18 S-1-13\r\nEPA ERLN Laboratory Requirements 3.2.6\r\nEPA ERLN Laboratory Requirements 4.9.11\n\n32.15 The system should provide a clear alert or notification upon entry of out-of-specification results.\n\n\nASTM E1578-18 S-1-14\n\n32.16 The system shall allow authorized personnel to update static and dynamic data.\n\n\nASTM E1578-18 S-1-15\n\n32.17 The system should allow workflow events and status changes to trigger one or more user-defined actions.\n\n\nASTM E1578-18 S-1-17\r\nCJIS Security Policy 5.7.1\r\nNIST 800-53, Rev. 5, AC-6(1)\r\nNIST 800-53, Rev. 5, CM-7\n\n32.18 The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n\n\nASTM E1578-18 S-1-18\r\nCAP Laboratory Accreditation Manual\n\n32.19 The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n\n\nASTM E1578-18 S-1-19\n\n32.20 The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-20\r\nE.U. Annex 11-14\r\nNIST 800-53, Rev. 5, CM-5(1)\r\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n32.21 The system should support rules governing electronic records and electronic signatures in regulated environments.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n10 CFR Part 20.2110\r\n\n10 CFR Part 30.51 (c-1\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\nA2LA C211 4.13.1.4\r\n\nA2LA C211 5.4.7.2\r\n\nAAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.1\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.3\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nASTM E1578-18 S-1-16\r\n\nASTM E1578-18 S-1-21\r\n\nCJIS Security Policy 5.5.2\r\n\nCLSI QMS22 2.4.3\r\n\nE.U. Annex 11-12\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nEPA ERLN Laboratory Requirements 4.9.4 and 4.9.14\r\n\nICH GCP 2.10\r\n\nISO\/IEC 17025:2017 4.2.1\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, CM-5 and CM-5(1)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nPFP Human and Animal Food Testing Laboratories Best Practices Manual\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n\n\n\nBRC GSFS, Issue 8, 3.2.1\r\n\nBRC GSFS, Issue 8, 3.3.1\r\n\nCJIS Security Policy 5.5.2.2\u20133\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-2(11)\n\n\n32.23 The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n\n\nASTM E1578-18 S-1-22\r\nNIST 800-53, Rev. 5, IA-2(10)\n\n32.24 The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.6.1\r\n\nCLSI QMS22 2.4.2.2\r\n\nE.U. Annex 11-14\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 7.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.9.4\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.25 The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n\n\n\n21 CFR Part 11.300 (a)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-4 and IA-5\n\n\n32.26 The system shall prevent the same combination of identification components from being used across more than one account.\n\n\n\n21 CFR Part 11.300 (b)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCLSI QMS22 2.4.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, IA-5 and IA-5(1)\n\n\n32.27 The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n\n\nCJIS Security Policy 5.6.3.1\r\nNIST 800-53, Rev. 5, AC-2(3)\r\nNIST 800-53, Rev. 5, IA-4 and IA-5(1)\r\nNIST 800-53, Rev. 5, PS-4\n\n32.28 The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n\n\nCJIS Security Policy 5.5.2.2\r\nNIST 800-53, Rev. 5, AC-10\n\n32.29 The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n\n\nCJIS Security Policy 5.5.4\r\nNIST 800-53, Rev. 5, AC-8\n\n32.30 The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n\n\n\n21 CFR Part 11.300 (d)\r\n\n21 CFR Part 211.68\r\n\n21 CFR Part 211.100\r\n\n21 CFR Part 211.160 (a)\r\n\n21 CFR Part 211.188\r\n\n21 CFR Part 211.194\r\n\nA2LA C211 4.13.2.1\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCAP Laboratory Accreditation Manual\r\n\nCJIS Security Policy 5.4.1.1\r\n\nCLSI QMS22 2.4.4\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, CM-5(1)\r\n\nWADA International Standard for Laboratories (ISL) 5.2.3.5\r\n\nWHO Technical Report Series, #986, Annex 2, 15.9\n\n\n32.31 The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n\n\n\n21 CFR Part 11.300 (d)\r\n\nASTM E1578-18 E17-5 and S-3-1\r\n\nCJIS Security Policy 5.5.3\r\n\nISO 15189:2012 5.10.3\r\n\nNIST 800-53, Rev. 5, AC-7\n\n\n32.32 The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n\n\n21 CFR Part 11.200 (a)\r\nASTM E1578-18 S-3-1\n\n32.33 The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.200 (a)\r\n\n21 CFR Part 211.68 (b)\r\n\n21 CFR Part 211.188 (b-11)\r\n\n21 CFR Part 211.194 (a-7 and a-8)\r\n\n21 CFR Part 212.50 (c-10)\r\n\n42 CFR Part 73.11\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.6.3.2\r\n\nNIST 800-53, Rev. 5, IA-5\n\n\n32.34 The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n42 CFR Part 73.11\r\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-1-25\r\n\nCJIS Security Policy 5.5.1\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nNIST 800-53, Rev. 5, AC-3\r\n\nNIST 800-53, Rev. 5, IA-2, IA-5, and IA-8\n\n\n32.35 The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n\n\n\n21 CFR Part 11.100 (a)\r\n\n45 CFR Part 164.312\r\n\nASTM E1578-18 S-1-24\r\n\nE.U. Annex 11-14\r\n\nNIST 800-53, Rev. 5, AU-10 and AU-10(3)\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.36 The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n\n\n21 CFR Part 11.100 (a)\r\nASTM E1578-18 S-1-24\r\nNIST 800-53, Rev. 5, AU-10 and AU-10(3)\n\n32.37 The system shall prevent the reuse or reassignment of a user's electronic signature.\n\n\n21 CFR Part 11.50\r\nE.U. Annex 11-14\n\n32.38 When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n\n\n\nASTM E1578-18 S-1-26\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nCLSI QMS22 2.8.5.3\r\n\nWHO Technical Report Series, #996, Annex 5, Appendix 1\n\n\n32.39 The system should provide a means to migrate static data into the system.\n\n\nNIST 800-53, Rev. 5, IA-5(1)\r\nCLSI QMS22 2.4.2\n\n32.40 The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n\n\nNIST 800-53, Rev. 5, IA-6\n\n32.41 The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n\n\n\n33. System validation and commission \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\nASTM E1578-18 S-2-1\r\nCJIS Security Policy Appendix G.8\r\nNIST 800-53, Rev. 5, SA-4(3)\n\n33.1 The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n\n\nASTM E1578-18 S-2-2\r\nNIST 800-53, Rev. 5, SA-4(2)\n\n33.2 The vendor should be willing to provide access to source code through a suitable escrow.\n\n\nASTM E1578-18 S-2-3\n\n33.3 The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n\n\n\nA2LA C211 5.4.7.2\r\n\nASTM E1578-18 S-2-4\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.5\r\n\nNIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5\n\n\n33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n\n\n\n21 CFR Part 11.10 (a)\r\n\n21 CFR Part 820.70 (i)\r\n\nA2LA C211 5.4.7.2\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nCAP Laboratory Accreditation Manual\r\n\nCLSI QMS22 2.5\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nE.U. Annex 11-11\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nE.U. Commission Directive 2003\/94\/EC Article 9.2\r\n\nISO 15189:2012 5.10.3\r\n\nISO\/IEC 17025:2017 7.11.2\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nOECD GLP Principles 4.1\r\n\nTNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)\r\n\nWHO Technical Report Series, #996, Annex 5, 10.2\n\n\n33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n\n\nASTM E1578-18 S-2-2\r\nCLSI QMS22 2.5\r\nE.U. Annex 11-4\r\nWHO Technical Report Series, #996, Annex 5, 10.3\u20137\n\n33.6 The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n\n\n\n34. System administration \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n21 CFR Part 11.200 (a)\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-5)\r\n\nASTM E1578-18 S-3-1\r\n\nCJIS Security Policy 5.5.5\r\n\nCLSI QMS22 2.4.2\r\n\nNIST 800-53, Rev. 5, AC-11 and AC-12\n\n\n34.1 The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n\n\nASTM E1578-18 S-3-2\n\n34.2 The system should provide a means for modifying personnel data in a batch.\n\n\nASTM E1578-18 S-3-3\n\n34.3 The system should support the storage of standard and industry-specific data formats.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (d)\r\n\n21 CFR Part 211.68 (b)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.308\r\n\n45 CFR Part 164.514\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-7\r\n\nCJIS Security Policy 5.5.1\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy Appendix G.5\r\n\nCLSI QMS22 2.4.2\r\n\nEPA 815-R-05-004 Chap. IV, Sec. 8.6\r\n\nEPA 815-R-05-004 Chap. VI, Sec. 8.6\r\n\nEPA ERLN Laboratory Requirements 4.1.14\u201315\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.8.7.1\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nISO\/IEC 17025:2017 8.3.2\r\n\nNIST 800-53, Rev. 5, AC-2(7) and AC-3\r\n\nNIST 800-53, Rev. 5, IA-2 and IA-8\r\n\nNIST 800-53, Rev. 5, MA-4\r\n\nNIST 800-53, Rev. 5, PS-4 and PS-5\r\n\nUSDA Administrative Procedures for the PDP 5.2.4\r\n\nUSDA Administrative Procedures for the PDP 5.5.1.2\r\n\nWHO Technical Report Series, #996, Annex 5, 5.4 and Appendix 1\n\n\n34.4 The system shall support the ability to define, record, and change the level of access for individual users to system groups, roles, machines, processes, and objects based on their responsibilities, including when those responsibilities change. The system should be able to provide a list of individuals assigned to a given system group, role, machine, process, or object.\n\n\nASTM E1578-18 S-3-8\n\n34.5 The vendor should provide maintenance agreements and support services for its applications and services.\n\n\nASTM E1578-18 S-3-9\r\nE.U. Annex 11-3.3\r\nNIST 800-53, Rev. 5, SA-16\r\nUSDA Administrative Procedures for the PDP 5.2.4\n\n34.6 The vendor shall provide help desk, training, and installation support, as well as high-quality system documentation. The documentation should be reviewed to ensure that user requirements are fulfilled.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n21 CFR Part 11.10 (c)\r\n\n42 CFR Part 73.11\r\n\n45 CFR Part 164.310\r\n\nAAVLD Requirements for an AVMDL Sec. 5.4.4.3\r\n\nABFT Accreditation Manual Sec. D-5\u2013D-8\r\n\nASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1\r\n\nASTM E1492-11 4.2.4\r\n\nCJIS Security Policy 5.5.2\r\n\nCJIS Security Policy 5.8.1\r\n\nEPA ERLN Laboratory Requirements 4.9.6\r\n\nE.U. Annex 11-7.1\r\n\nE.U. Annex 11-12\r\n\nISO 15189:2012 5.10.2\r\n\nISO\/IEC 17025:2017 7.11.3\r\n\nNIST 800-53, Rev. 5, MA-5\r\n\nNIST 800-53, Rev. 5, MP-2\r\n\nNIST 800-53, Rev. 5, PE-3, PE-3(1), PE-6, PE-6(1), and PE-6(4)\r\n\nUSDA Administrative Procedures for the PDP 5.2.1\n\n\n34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)\n\n\nCJIS Security Policy 5.5.1\n\n34.8 The system shall be able to tag and document an individual, group, and system account as having been validated for regulatory purposes, and remind the administrator or authorized personnel on a configurable schedule when the account should be validated again.\n\n\n\n7 CFR Part 331.17\r\n\n9 CFR Part 121.17\r\n\n42 CFR Part 73.17\r\n\nASTM E1578-18 S-3-10\n\n\n34.9 The system should provide a means of integrating with an enterprise personnel security directory, as well as physical security systems.\n\n\n\n7 CFR Part 331.11\r\n\n9 CFR Part 121.11\r\n\n42 CFR Part 73.11\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C5.7\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nASTM E1578-18 S-3-11\r\n\nCJIS Security Policy 5.10.4.1\r\n\nCLSI QMS22 2.1.4\r\n\nCLSI QMS22 2.6.1\r\n\nEPA ERLN Laboratory Requirements 4.9.13\r\n\nNIST 800-53, Rev. 5, SI-2(5)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\n\n\n34.10 The vendor should provide timely upgrades and patches, with complete documentation, that have been tested before installation and can be rolled back.\n\n\nASTM E1578-18 S-3-12\n\n34.11 The system shall provide a means for migrating data to a new release upon system upgrade.\n\n\n21 CFR Part 1.1154 (b)\r\nASTM E1578-18 S-3-13\n\n34.12 The system should be expedient with the retrieval of stored items.\n\n\n\n21 CFR Part 11.10 (b)\r\n\nAPHL 2019 LIS Project Management Guidebook\r\n\nE.U. Annex 11-5\r\n\nE.U. Annex 11-8.1\n\n\n34.13 The system shall allow the printing of stored electronic records in a complete, accurate, and human-readable format.\n\n\nASTM E1578-18 S-3-14\n\n34.14 The system should provide some sort of support for use on mobile technologies, particularly for the purpose of receiving notifications and monitoring processes.\n\n\nASTM E1578-18 S-3-15\r\nEPA ERLN Laboratory Requirements 4.9.13\r\nNIST 800-53, Rev. 5, CM-3(2)\r\nNIST 800-53, Rev. 5, SI-2\n\n34.15 The system shall be able to install an upgrade into a test environment for testing purposes before upgrading the actual production environment.\n\n\n\n35. Cybersecurity \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d-9)\r\n\nASTM E1578-18 S-4-1\r\n\nCJIS Security Policy 5.6.4\r\n\nCJIS Security Policy 5.8.2.1\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nCLSI QMS22 2.2.3.2\r\n\nEMA Guidance on Good Manufacturing Practice and Good Distribution Practice\r\n\nNIST 800-53, Rev. 5, AC-17(2)\r\n\nNIST 800-53, Rev. 5, MA-4(6)\r\n\nNIST 800-53, Rev. 5, SC-8 and SC-8(1)\n\n\n35.1 The system should use secure communication protocols like SSL\/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.\n\n\n\n42 CFR Part 493.1231\r\n\n45 CFR Part 164.312\r\n\n45 CFR Part 170.315 (d)\r\n\nACMG Technical Standards for Clinical Genetics Laboratories C1.6\r\n\nASTM E1578-18 S-4-2\r\n\nCJIS Security Policy 5.5.2.4\r\n\nCJIS Security Policy 5.10.1.2\r\n\nCJIS Security Policy Appendix G.6\r\n\nNIST 800-53, Rev. 5, CP-9(8)\r\n\nNIST 800-53, Rev. 5, SC-13 and SC-28(1)\n\n\n35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.\n\n\n42 CFR Part 493.1231\r\nCJIS Security Policy 5.6.2.2.1\r\nCLSI QMS22 2.4.2.2\r\nNIST 800-53, Rev. 5, AC-3\r\nNIST 800-53, Rev. 5, IA-2, IA-2(1\u20134), and IA-8\r\nNIST 800-53, Rev. 5, MA-4\n\n35.3 The system should be able to support multifactor authentication.\n\n\n45 CFR Part 170.202\r\n45 CFR Part 170.315 (h)\n\n35.4 The system should support Office of the National Coordinator for Health Information Technology (ONC) transport standards and protocols for the reception and distribution of personal health information.\n\n\nNIST 800-53, Rev. 5, IA-7\n\n35.5 The system should provide a means for authenticating an individual seeking to access any embedded cryptographic module within the system, as well as the individual's role in performing services within the module.\n\n\nNIST 800-53, Rev. 5, SC-15\n\n35.6 The system should prevent connected collaborative computing devices (e.g., cameras, microphones, interactive whiteboards) from being activated without explicit permission from the end user, and it should provide a clear indication of any activation to the end user.\n\n\n\n36. Information privacy \n\n\n\n\n\n\n\n\n\nRegulation, Specification, or Guidance\n\nRequirement\n\n\n45 CFR Part 164 Subpart E\r\nACMG Technical Standards for Clinical Genetics Laboratories G17.2\r\nASTM E1578-18 S-5-1\r\nCAP Laboratory Accreditation Manual\r\nNIST 800-53, Rev. 5, PT-2 and PT-2(2)\n\n36.1 The system shall comply with privacy protection compliance like that found in HIPAA provisions.\n\n\n\n10 CFR Part 20.2106 (d)\r\n\n45 CFR Part 164.105\r\n\n45 CFR Part 164 Subpart C\r\n\n45 CFR Part 170.315 (d)\r\n\nASTM E1578-18 S-5-2\r\n\nICH GCP 2.11\r\n\nNIST 800-53, Rev. 5, PT-2 and PT-2(2)\r\n\nNYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards\r\n\nWADA International Standard for Laboratories (ISL) 5.3.8.3\r\n\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) (throughout)\n\n\n36.2 The system should be provisioned with enough security to automatically enforce verification mechanisms that prevent personally identifiable information in the system from being compromised.\n\n\n45 CFR Part 164.514\r\nACMG Technical Standards for Clinical Genetics Laboratories C5.5\r\nCAP Laboratory Accreditation Manual\r\nNIST 800-53, Rev. 5, SI-19\r\nWADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.3\n\n36.3 The system shall allow authorized individuals to de-identify select data in the system, including but not limited to names, geographic locations, dates, government-issued identification numbers, telephone numbers, email addresses, full-face photos, and other personal identifiers.\n\n\n45 CFR Part 164 Subpart E\r\nNIST 800-53, Rev. 5, AC-6\r\nNIST 800-53, Rev. 5, SI-19\n\n36.4 The system shall be able to verify and ensure that users authorized to view de-identified data are also not a member of a role that permits access to information that re-identifies the data, i.e., segregate duties.\n\n\nNIST 800-53, Rev. 5, SI-19(7)\n\n36.5 The system should use validated algorithms to de-identify data in the system and be validated to use those algorithms.\n\n\nNIST 800-53, Rev. 5, PT-4 and PT-4(3)\n\n36.6 The system should provide tools or mechanisms for recording the consent\u2014and revocation of consent\u2014of individuals who wish to allow\u2014or disallow\u2014their personally identifiable information to be processed, stored, and otherwise managed.\n\n\n\nReferences \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Blank_LIMSpec_template_for_manufacturing_labs\/Security_and_integrity_of_systems_and_operations<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 16 May 2023, at 22:09.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed once.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","8dba7922c519f23896ea896ed1a6beab_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Security_and_integrity_of_systems_and_operations rootpage-Book_LIMS_Selection_Guide_for_Manufacturing_Quality_Control_Blank_LIMSpec_template_for_manufacturing_labs_Security_and_integrity_of_systems_and_operations skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for Manufacturing Quality Control\/Blank LIMSpec template for manufacturing labs\/Security and integrity of systems and operations<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_Manufacturing_Quality_Control\/Introduction\" title=\"Book:LIMS Selection Guide for Manufacturing Quality Control\/Introduction\" class=\"wiki-link\" data-key=\"fff6bb59eb24072ae3ca737e0ffb2c60\">the beginning<\/a> of this guide-----<\/div>\n<p><br \/>\n<\/p>\n<h2><span class=\"mw-headline\" id=\"A6._Security_and_integrity_of_systems_and_operations\">A6. Security and integrity of systems and operations<\/span><\/h2>\n<p><b>Note: These categories cover what <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> largely considers to be \"platform and administration support functions.\" Notably, most of the requirements here have something to do with ensuring the security and integrity of not only the system and its functions but also the data that it houses and modifies.<\/b>\n<\/p>\n<h3><span class=\"mw-headline\" id=\"31._Data_integrity\">31. Data integrity<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 9.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.1<\/b> System functionality should support ALCOA principles.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.2<\/b> The system shall protect entered data so as to prevent it from being obscured by new data, keeping both the old and current data available for review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1152 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.190\" target=\"_blank\">21 CFR Part 58.190<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.305\" target=\"_blank\">42 CFR Part 93.305<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.310\" target=\"_blank\">42 CFR Part 93.310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.2.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.3.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.8.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 8.1.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.3<\/b> The system shall securely maintain a true, readable copy of an instrument's original (raw) data for on-demand review.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/91.30\" target=\"_blank\">7 CFR Part 91.30<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.17\" target=\"_blank\">7 CFR Part 331.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/2.35\" target=\"_blank\">9 CFR Part 2.35<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.17\" target=\"_blank\">9 CFR Part 121.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2103\" target=\"_blank\">10 CFR Part 20.2103\u201310<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.34\" target=\"_blank\">10 CFR Part 30.34 (g)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51\u20132<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-1\" target=\"_blank\">21 CFR Part 1.1154 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/58.195\" target=\"_blank\">21 CFR Part 58.195<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-106\" target=\"_blank\">21 CFR Part 106.100 (n)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-112\" target=\"_blank\">21 CFR Part 112.164<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-114\" target=\"_blank\">21 CFR Part 114.100 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-117\" target=\"_blank\">21 CFR Part 117.315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-120\" target=\"_blank\">21 CFR Part 120.12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-123\" target=\"_blank\">21 CFR Part 123.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-129\" target=\"_blank\">21 CFR Part 129.80 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.180\" target=\"_blank\">21 CFR Part 211.180<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.110\" target=\"_blank\">21 CFR Part 212.110 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.42\" target=\"_blank\">21 CFR Part 225.42 (b-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.58\" target=\"_blank\">21 CFR Part 225.58 (c\u2013d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.102\" target=\"_blank\">21 CFR Part 225.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.110\" target=\"_blank\">21 CFR Part 225.110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.158\" target=\"_blank\">21 CFR Part 225.158<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/225.202\" target=\"_blank\">21 CFR Part 225.202<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.42\" target=\"_blank\">21 CFR Part 226.42 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.58\" target=\"_blank\">21 CFR Part 226.58 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.102\" target=\"_blank\">21 CFR Part 226.102<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/226.115\" target=\"_blank\">21 CFR Part 226.115<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.57\" target=\"_blank\">21 CFR Part 312.57<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/312.62\" target=\"_blank\">21 CFR Part 312.62<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-507\" target=\"_blank\">21 CFR Part 507.208<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/606.160\" target=\"_blank\">21 CFR Part 606.160 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/812.140\" target=\"_blank\">21 CFR Part 812.140 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.180\" target=\"_blank\">21 CFR Part 820.180 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.120\" target=\"_blank\">29 CFR Part 1910.120 (f)(8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/29\/1910.1030\" target=\"_blank\">29 CFR Part 1910.1030 (h-2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.33\" target=\"_blank\">40 CFR Part 141.33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/141.722\" target=\"_blank\">40 CFR Part 141.722<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.11\" target=\"_blank\">40 CFR Part 262.11 (f)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.40\" target=\"_blank\">40 CFR Part 262.40<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/262.213\" target=\"_blank\">40 CFR Part 262.213<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/part-704\/subpart-A\" target=\"_blank\">40 CFR Part 704 Subpart A<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/717.15\" target=\"_blank\">40 CFR Part 717.15 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.17\" target=\"_blank\">42 CFR Part 73.17 (c)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.313\" target=\"_blank\">42 CFR Part 93.313 (h)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/93.317\" target=\"_blank\">42 CFR Part 93.317<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1105\" target=\"_blank\">42 CFR Part 493.1105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1283\" target=\"_blank\">42 CFR Part 493.1283<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.105\" target=\"_blank\">45 CFR Part 164.105<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.316\" target=\"_blank\">45 CFR Part 164.316<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.530\" target=\"_blank\">45 CFR Part 164.530<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 310.25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 381.94<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.govinfo.gov\/app\/details\/FR-1996-07-25\/96-17837\/summary\" target=\"_blank\">61 FR 38806, 9 CFR Part 417.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/citeseerx.ist.psu.edu\/viewdoc\/download?doi=10.1.1.359.5506&rep=rep1&type=pdf\" target=\"_blank\">A2LA C223 5.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aafco.org\/Publications\/QA-QC-Guidelines-for-Feed-Laboratories\" target=\"_blank\">AAFCO QA\/QC Guidelines for Feed Laboratories Sec. 2.4.4 or 3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.abft.org\/files\/ABFT_LAP_Standards_May_31_2013.pdf\" target=\"_blank\">ABFT Accreditation Manual Sec. E-33<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C1.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories E2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.14.1.2 and 4.15.1.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.6 and 5.9.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cdc.gov\/labs\/BMBL.html\" target=\"_blank\">CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.3.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.6\u20137<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fao.org\/fao-who-codexalimentarius\/sh-proxy\/en\/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf\" target=\"_blank\">Codex Alimentarius CXC 1-1969, Ch.1, 7.4<\/a>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-7.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 11.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.8.d<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A02004R0852-20210324\" target=\"_blank\">E.U. Commission Reg. No. 852\/2004 Annex I, Section III.9.c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. III, Sec. 15<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.18<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.17<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/quality\/guidance-quality-assurance-project-plans-epa-qag-5\" target=\"_blank\">EPA QA\/G-5 2.1.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I - FSM 9.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 9.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/mygfsi.com\/news-and-resources\/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications\" target=\"_blank\">GFSI Benchmarking Rqmts., v2020.1, Part 3, K - FSM 9.2.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 4.9.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_food7\/documents\/standards\/IFS_Food7_en.pdf\" target=\"_blank\">IFS Food 7, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ifs-certification.com\/images\/standards\/ifs_pacsecure2\/documents\/standards\/IFS_pacsecure2_en.pdf\" target=\"_blank\">IFS PACsecure 2, Part 2, 2.1.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 8.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AT-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-11 and AU-11(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1020\" target=\"_blank\">OSHA 1910.1020(d)(1)(i\u2013ii)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.osha.gov\/laws-regs\/regulations\/standardnumber\/1910\/1910.1450\" target=\"_blank\">OSHA 1910.1450(j)(2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Division 3, 48 (4)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-2018-108\/index.html\" target=\"_blank\">Safe Food for Canadians Regulations SOR\/2018-108 Part 5, 90<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf\" target=\"_blank\">SQF FSC 9, Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_PetFood_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Pet Food Manufacturing, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.sqfi.com\/wp-content\/uploads\/2020\/11\/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf\" target=\"_blank\">SQF FSC 9, Manufacture of Food Packaging, Part B, 2.2.3.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (throughout)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/sites\/default\/files\/media\/TestingGuidelinesforHemp.pdf\" target=\"_blank\">USDA Hemp Production Program Laboratory Testing Guidelines, Information Sharing 2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/services\/lab-testing\/lab-approval\" target=\"_blank\">USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 10c<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5 and 5.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-protection-privacy-and-personal\" target=\"_blank\">WADA International Standard for the Protection of Privacy and Personal Information (ISPPPI) 10.0<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.8\u20139<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 11.15 and Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.4<\/b> The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 4.12 and Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.5<\/b> The system shall accurately reflect the system date and time in its use of electronic record time stamps.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-7<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.6<\/b> The system shall require each and every user to be assigned a unique user ID.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E-17-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (e)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>31.7<\/b> The system shall prevent the modification, deletion, or disabling of its audit trail, as well as record such attempts.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SI-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>31.8<\/b> The system shall be capable of identifying instances of audit processing failure (e.g., write errors, general failure of the audit tool, etc.), sending alerts or notifications to appropriate personnel in such cases.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"32._Configuration_management\">32. Configuration management<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.1<\/b> The system shall provide tools to enter and manage user-configurable lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.2<\/b> The system shall allow authorized users to configure the specification limits for sample and instrument tests.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/162.1002\" target=\"_blank\">45 CFR Part 162.1002<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Sampling Procedures for PDP 6.3.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.3<\/b> The system shall allow system nomenclature to be configured to use specific data code sets\u2014such as the International Classification of Diseases or the Healthcare Common Procedure Coding System\u2014or mandated terminology to support regulatory requirements.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.4<\/b> The system should allow authorized personnel to configure the review and approval of multiple tests at the sample, batch, project, and experiment levels.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.5<\/b> The system should allow warning and material specification limits to be entered and configured so as to allow their comparison against entered results and determinations for determining whether the results meet those specifications or limits.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100 (b)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.6<\/b> The system should provide a configurable means of allowing the system to automatically save after each entry to help meet ALCOA, CGMP, and other requirements to contemporaneously record data into records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.10\" target=\"_blank\">40 CFR Part 3.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/40\/3.2000\" target=\"_blank\">40 CFR Part 3.2000<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C13.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.7<\/b> The system should provide a configurable (based on sample, test, or both) means of permitting electronic signatures for both entered results and approved reports.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.8<\/b> The system should be capable of providing a complete list of all pending tests loaded in the system, the amount of material required for each test, and to which location the associated samples are to be sent for testing.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.9<\/b> The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.10<\/b> The system shall allow authorized personnel to assign status values for purposes of tracking sample progress or other portions of laboratory workflow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-9<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.11<\/b> The system should allow authorized personnel to perform revision control of lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-10<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.12<\/b> The system should provide a means for importing lookup or master data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/policies\" target=\"_blank\">AIHA-LAP Policies 2022 2A.7.8.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.11.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Data and Instrumentation for PDP 9.1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.13<\/b> The system shall be able to define the number of significant figures (i.e., set rounding rules) for reported numeric data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-12<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.14<\/b> The system should allow calculated limits to be created and managed based on test results and relevant metadata.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-13<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 3.2.6<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.11<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.15<\/b> The system should provide a clear alert or notification upon entry of out-of-specification results.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.16<\/b> The system shall allow authorized personnel to update static and dynamic data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-15<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.17<\/b> The system should allow workflow events and status changes to trigger one or more user-defined actions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-17<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.7.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-6(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-7<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.18<\/b> The system should provide an interface for administrative access that permits approved users to configure the system without extra programming or manipulation of data storage systems.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-18<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.19<\/b> The system should allow administrators to programmatically customize system modules or build calculations within the application, while also accurately documenting those system modifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-19<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.20<\/b> The system should provide a multiuser interface that can be configured to local user needs, including display language, character sets, and time zones.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-20<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.21<\/b> The system should support rules governing electronic records and electronic signatures in regulated environments.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/20.2110\" target=\"_blank\">10 CFR Part 20.2110<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/10\/30.51\" target=\"_blank\">10 CFR Part 30.51 (c-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 4.10.1.3\u20134<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aavld.org\/accreditation-requirements-page\" target=\"_blank\">AAVLD Requirements for an AVMDL Sec. 5.4.4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1492-11r17.html\" target=\"_blank\">ASTM E1492-11 4.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-16<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-21<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-12<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4 and 4.9.14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ichgcp.net\/\" target=\"_blank\">ICH GCP 2.10<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 4.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5 and CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pfp-ifss.org\/ifss-resources\/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018\/\" target=\"_blank\">PFP Human and Animal Food Testing Laboratories Best Practices Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 4.13.1.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ams.usda.gov\/datasets\/pdp\/pdp-standard-operating-procedures\" target=\"_blank\">USDA Administrative Procedures for the PDP 5.2.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.22<\/b> The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/cdn.scsglobalservices.com\/files\/program_documents\/brc_food_standard_8_0.pdf\" target=\"_blank\">BRC GSFS, Issue 8, 3.3.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2\u20133<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(11)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.23<\/b> The system shall be able to granularly define access control down to the object level, role level, physical location, logical location, network address, and chronometric restriction level for the protection of regulated, patented, confidential, and classified data, methods, or other types of information.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-22<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2(10)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.24<\/b> The system should support single sign-on such that a user can log in once and access all permitted functions and data.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/des.wa.gov\/sites\/default\/files\/public\/documents\/About\/1063\/RFP\/Add7_Item4ASCLD.pdf\" target=\"_blank\">ASCLD\/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.4.7.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 7.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.9.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(7) and AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, MA-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/extranet.who.int\/prequal\/content\/who-technical-report-series\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.25<\/b> The system shall provide initial login access using at least two unique identification components, e.g., a user identifier and password, or biometric information linked to and used by the genuine user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.26<\/b> The system shall prevent the same combination of identification components from being used across more than one account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5 and IA-5(1)<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.27<\/b> The system shall allow the administrator to define a time period in days after which a user will be prompted to change their password.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-2(3)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-4 and IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, PS-4<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.28<\/b> The system shall allow the administrator to define a time period of inactivity for a user identifier, after which it will be disabled and archived.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.2.2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-10<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.29<\/b> The system shall allow the administrator or authorized personnel to configure the allowance or prevention of multiple concurrent active sessions for one unique user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-8<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.30<\/b> The system shall allow the administrator or authorized personnel to configure approved system use (e.g., \"you are accessing a restricted information system,\" \"system use indicates consent to being monitored, recorded, and audited\") and other types of notifications to appear before or after a user logs in to the system. These notifications should remain on the screen until acknowledged by the user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.100\" target=\"_blank\">21 CFR Part 211.100<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.160\" target=\"_blank\">21 CFR Part 211.160 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 4.13.2.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.4.1.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, CM-5(1)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wada-ama.org\/en\/resources\/world-anti-doping-program\/international-standard-laboratories-isl\" target=\"_blank\">WADA International Standard for Laboratories (ISL) 5.2.3.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.who.int\/medicines\/areas\/quality_safety\/quality_assurance\/expert_committee\/trs_986\/en\/\" target=\"_blank\">WHO Technical Report Series, #986, Annex 2, 15.9<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.31<\/b> The system shall keep an accurate audit trail of login activities, including failed login attempts, unauthorized logins, and electronic signings.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.300\" target=\"_blank\">21 CFR Part 11.300 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 E17-5 and S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-7<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.32<\/b> The system shall allow the administrator or authorized personnel to define the number of failed login attempts before the system locks the user out.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.33<\/b> The system shall require at least one unique identification component for additional electronic signings (beyond initial login) during a single, continuous session.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.68\" target=\"_blank\">21 CFR Part 211.68 (b)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.188\" target=\"_blank\">21 CFR Part 211.188 (b-11)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/211.194\" target=\"_blank\">21 CFR Part 211.194 (a-7 and a-8)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/212.50\" target=\"_blank\">21 CFR Part 212.50 (c-10)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.6.3.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.34<\/b> The vendor shall provide training materials emphasizing the importance of not sharing unique identification components with other individuals and promoting compliance review for ensuring such practices are followed.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/7\/331.11\" target=\"_blank\">7 CFR Part 331.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/9\/121.11\" target=\"_blank\">9 CFR Part 121.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/73.11\" target=\"_blank\">42 CFR Part 73.11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/42\/493.1231\" target=\"_blank\">42 CFR Part 493.1231<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.308\" target=\"_blank\">45 CFR Part 164.308<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.514\" target=\"_blank\">45 CFR Part 164.514<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-25<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.epa.gov\/sites\/production\/files\/documents\/erln_lab_requirements.pdf\" target=\"_blank\">EPA ERLN Laboratory Requirements 4.1.14\u201315<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-2, IA-5, and IA-8<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.35<\/b> The system shall support the ability to initially assign new individual users to system groups, roles, or both.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.36<\/b> The system shall force a user's electronic signature to be unique and traceable to a specific user's account.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.100\" target=\"_blank\">21 CFR Part 11.100 (a)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-24<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AU-10 and AU-10(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.37<\/b> The system shall prevent the reuse or reassignment of a user's electronic signature.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.50\" target=\"_blank\">21 CFR Part 11.50<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-14<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.38<\/b> When the system generates a complete and accurate copy of an electronically signed record, it shall also display the printed name of the signer, the date and time of signature execution, and any applicable meaning associated with the signature. This shall be applicable for both electronically displayed and printed copies of the electronic record.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-1-26<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/GH-2019May-LIS-Guidebook-web.pdf\" target=\"_blank\">APHL 2019 LIS Project Management Guidebook<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.8.5.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, Appendix 1<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>32.39<\/b> The system should provide a means to migrate static data into the system.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-5(1)<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.40<\/b> The system should provide a means for automatically authenticating if a user's proposed password meets the length, complexity, minimum number of changed characters, and other requirements as configured by the administrator or another authorized system user.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, IA-6<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>32.41<\/b> The system should provide a means for obscuring authentication feedback as it is entered into the system, e.g., displaying asterisks rather than the typed password or displaying actual typed feedback for a distinctly short period of time before obscuring it.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"33._System_validation_and_commission\">33. System validation and commission<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-1<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy Appendix G.8<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(3)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.1<\/b> The vendor should be able to demonstrate the use of software development standards, secure coding practices, formal change control, and software revision control within its development practices. The vendor should also document its staff's skills and certifications.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(2)<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.2<\/b> The vendor should be willing to provide access to source code through a suitable escrow.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-3<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.3<\/b> The system should be able to document a summary and evaluation of enterprise performance markers and processes.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-4<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, SA-4(1), SA-4(2), and SA-5<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.4<\/b> The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.10\" target=\"_blank\">21 CFR Part 11.10 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/820.70\" target=\"_blank\">21 CFR Part 820.70 (i)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.uslegalforms.com\/form-library\/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation\" target=\"_blank\">A2LA C211 5.4.7.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.acmg.net\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards\/ACMG\/Medical-Genetics-Practice-Resources\/Genetics_Lab_Standards.aspx\" target=\"_blank\">ACMG Technical Standards for Clinical Genetics Laboratories C5.7<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/elss.cap.org\/elss\/ShowProperty?nodePath=\/UCMCON\/Contribution%20Folders\/DctmContent\/education\/OnlineCourseContent\/2017\/LAP-TLTM\/misc\/lam.pdf\" target=\"_blank\">CAP Laboratory Accreditation Manual<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/research-development\/compliance\/good-manufacturing-practice\/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers\" target=\"_blank\">EMA Guidance on Good Manufacturing Practice and Good Distribution Practice<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-11<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. IV, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nepis.epa.gov\/Exe\/ZyPDF.cgi?Dockey=30006MXP.PDF\" target=\"_blank\">EPA 815-R-05-004 Chap. VI, Sec. 8.6<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/eur-lex.europa.eu\/eli\/dir\/2003\/94\/oj\" target=\"_blank\">E.U. Commission Directive 2003\/94\/EC Article 9.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\">ISO 15189:2012 5.10.3<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\">ISO\/IEC 17025:2017 7.11.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.wadsworth.org\/regulatory\/clep\/clinical-labs\/laboratory-standards\" target=\"_blank\">NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.oecd.org\/chemicalsafety\/testing\/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm\" target=\"_blank\">OECD GLP Principles 4.1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ris.dls.virginia.gov\/uploads\/1VAC30\/dibr\/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf\" target=\"_blank\">TNI EL-V1-2016-Rev.2.1 (V1,M2 5.4.7.2)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.2<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>33.5<\/b> The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.\n<\/td><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-2-2<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.5<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-4\/annex11_01-2011_en.pdf\" target=\"_blank\">E.U. Annex 11-4<\/a><br \/><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.gmp-compliance.org\/guidelines\/gmp-guideline\/who-guidance-on-good-data-and-record-management-practices\" target=\"_blank\">WHO Technical Report Series, #996, Annex 5, 10.3\u20137<\/a>\n<\/td>\n<td style=\"background-color:white;\"><b>33.6<\/b> The documentation associated with system validation shall discuss all applicable steps of the life cycle, justify applied methods and standards, and include change control records and observed deviations during validation, if applicable.\n<\/td><\/tr>\n<\/tbody><\/table>\n<\/td><\/tr><\/tbody><\/table>\n<h3><span class=\"mw-headline\" id=\"34._System_administration\">34. System administration<\/span><\/h3>\n<table style=\"\">\n<tbody><tr>\n<td style=\"vertical-align:top;\">\n<table class=\"wikitable collapsible\" border=\"1\" cellpadding=\"10\" cellspacing=\"0\" style=\"\">\n\n<tbody><tr>\n<th colspan=\"2\" style=\"text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;\">\n<\/th><\/tr>\n<tr>\n<th style=\"color:brown; background-color:#ffffee; width:500px;\">Regulation, Specification, or Guidance\n<\/th>\n<th style=\"color:brown; background-color:#ffffee; width:700px;\">Requirement\n<\/th><\/tr>\n<tr>\n<td style=\"padding:5px; width:500px;\">\n<p><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/11.200\" target=\"_blank\">21 CFR Part 11.200 (a)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/164.312\" target=\"_blank\">45 CFR Part 164.312<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/45\/170.315\" target=\"_blank\">45 CFR Part 170.315 (d-5)<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.astm.org\/e1578-18.html\" target=\"_blank\">ASTM E1578-18 S-3-1<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.fbi.gov\/services\/cjis\/cjis-security-policy-resource-center\" target=\"_blank\">CJIS Security Policy 5.5.5<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/clsi.org\/standards\/products\/quality-management-systems\/documents\/qms22\/\" target=\"_blank\">CLSI QMS22 2.4.2<\/a><br \/>\n<a rel=\"external_link\" class=\"external text\" href=\"https:\/\/csrc.nist.gov\/publications\/detail\/sp\/800-53\/rev-5\/final\" target=\"_blank\">NIST 800-53, Rev. 5, AC-11 and AC-12<\/a>\n<\/p>\n<\/td>\n<td style=\"background-color:white;\"><b>34.1<\/b> The system shall provide administrators with a configurable period of time to apply to user access or inactivity before again prompting a user for authentication credentials. The system shall also be able to display an explicit message indicating how much time remains before the user session terminates.\n<\/t
