Over the last 10 years, laboratory information management systems (LIMS) have changed beyond recognition. Increased regulatory requirements have meant that much more data is now being recorded; data that must be turned into useful information that is immediately available across the enterprise.
In August 1997, the United States Food and Drug Administration (FDA) issued a set of regulations entitled 21 CFR 11 (Title 21 of the Code of Federal Regulations, Part 11). “These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with the FDA’s responsibility to promote and protect public health.” The regulations set standards for systems containing electronic records and electronic signatures and standards for the use of such systems with respect to the release of safe consumables into the marketplace.
An interesting, recent press release on this website prompted a very funny picture in my head that I thought I would write about...
There are over 130 LIMS companies world wide and most industry reports estimate the annual LIMS market to be around $300 million per year. There is something very wrong with this picture.
About 3 to 4 months ago, I wrote an article entitled: "The King is Dead, Long live the King". Today I read a rebutal to that article from the servant of the old King. I found the article lively and entertaining to say the least but I do believe it went a little over the top.
The FBI recently announced the cancellation of a major IT project where nearly $170 Million dollars and 3 years were spent to end up with a system that only does 10% of what was envisioned.
In an era of increased competitiveness, economic uncertainty, ever-increasing regulation and global turmoil, companies are striving to continually improve operational efficiency. Many are looking to information technology to provide reductions in operating costs and increased efficiency by automating and streamlining existing business processes. This article outlines the experiences of one company, Altrix Heathcare plc as they implemented their laboratory information management system.
This is a great time of year for all people across the world. LIMSfinder.com is generally such a serious site, we have decided to lighten things up for the holidays and present something entertaining.
If GXP, data integrity, and reproducibility are of highest priority to a laboratory, it must routinely assess its Facilities, Methods or SOP’s, Personnel, Support system, Analytical Instruments, Microbiological Instruments, Standards and Materials and Laboratory Information Management Mechanism. The mirror image of a GXP laboratory should mimic the following minimum criteria and requirements as part of its construct.
There are several areas to consider in establishing your LIMS requirements and specifications. In times of constrained resources and budgets, you can ill afford unnecessary spending. Purchasing a LIMS is a sound decision that can potentially save your organization time and money. However, before making your purchase decision you should have an understanding of what drives LIMS costs.
The purpose of this article is to examine the benefit or value a Laboratory Information Management System (LIMS) can bring to your organization. We have all heard the adage “Time is Money”. In the business world, where bean-counters rule, this simple statement must be embraced if you want to continue to succeed. Time is the fixed or consistent part of the equation. Productivity, or how we use that time, is the variable. So how does a LIMS figure into this equation?
We live in wondrous times... The Internet is becoming a staple of life and the common man is now able to go to space. The times are changing and the old standards are becoming obsolete.
The “Monster LIMS” of the past could be the dinosaurs of the Lab Industry. These huge under takings have given the LIMS (Laboratory Information Management System) acronym a bad name. Many companies have spent hundreds of thousands or even millions on a product that is so complicated and resource draining that it sometimes never gets off the shelf.
Since the early 1990’s we in the environmental lab industry have seen many changes in the laboratory operation. The huge contract laboratories have combined, absorbed or just plain disappeared. Midsize labs became giants or also vanished with the environmental dollars. The small laboratories have been under the watchful eye of government, big brother, and anyone else that pays the bills.
Innaphase has been acquired by Thermo. What's next?
The purpose of document change control systems is to ensure that manufacturers build products that are safe and reliable. Good Manufacturing Processes (GMP) presume that both the process and documentation directing the process follow pre-approved methods, and any change to these methods is both restricted to authorized personnel, and tracked for future review. All FDA-regulated companies are mandated to have a document change control system.
ARUP Laboratories owned by the University of Utah (UU) is a leader in the laboratory testing market space. Serving clients in all 50 states, ARUP offers an extensive menu of over 2,000 diverse medical laboratory tests and test combinations, with a particular expertise in the more exotic analyses. Operating 24 hours a day, the company processes over 20,000 specimens of blood, body fluid, and tissue biopsies each day. Although ARUP maintains super human testing efficiency and turn around time, their success hasn't happen overnight.
Today there is much written and talked about when it comes to “Web Services”, but what does it mean to you and your laboratory data management systems. This article will address a specific technology that makes “Web Services” possible and useful to the laboratory.
This document will interpret and discuss the impact of the Guidance for Industry – Part 11, Electronic Records, Electronic Signatures – Scope and Application which was released as a final guidance for industry by the FDA in August of 2003.
A driver can be a very effective tool for transferring data from a source to
a destination because they are specifically designed to work within a very
clearly defined and fixed application. However, in the real world of
instrument interfacing each laboratory has unique needs and requirements
that are continually changing. In that environment the better choice is a
flexible solution that can be readily configured to meet each laboratory’s
specific needs.
