05/05/2020 - Strategies for Surviving an FDA Audit As part of its mission to ensure public safety, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. The FDA also inspects facilities that conduct clinical trials with humans and laboratories that conduct studies with animals or microorganisms when these studies are used to apply for FDA approval of a medical product. A typical inspection can last for 2-3 days and involves a number of key steps that you should be aware of.
05/05/2020 - Introducing STARLIMS Technology Platform V12 Abbott Informatics is proud to announce the availability of the STARLIMS Technology Platform v12. This milestone in the evolution of the Technology Platform (TP) brings numerous enhancements and fixes that will help with the proper operation and maintenance of your STARLIMS system.
05/05/2020 - Autoscribe Integrates Field Sample Planning and Scheduling Management Bringing new levels of field sampling optimization, compliance and field data collection, Autoscribe Informatics has announced the integration of Trilogy TAPS sample planning and scheduling management software with its Matrix Gemini configurable laboratory information management system (LIMS). Integration of field data collection and laboratory activities is especially useful in water, environmental, waste and similar industries.
05/05/2020 - CSV to CSA: A Paradigm Shift in Computerized Systems’ Approaches – or not? No more validation. CSV is a thing of the past. These are just some of the attention-grabbing headlines I’ve seen in various blogs and LinkedIn posts over the last 12 months about Computer System Assurance (CSA), and the reality couldn’t be more different. The U.S. FDA originally targeted their Case for Quality initiative (2011) at improving medical device quality and usability for patient safety. More recently, FDA’s Center for Devices and Radiological Health has sponsored an industry pilot team under the CSA title to improve Computer System Validation (CSV) approaches, as the existing practices were identified as a barrier to the adoption of new technologies. But, really, how much difference can there be between Validation and Assurance?
05/05/2020 - Benchling Launches Integrated Analytics Solution to Accelerate Life Science R&D Benchling, the leading life sciences R&D cloud, today announced the launch of Benchling Insights, a new solution that gives life sciences companies the ability to query, visualize and collaborate around high quality, structured data that resides on the platform. Benchling Insights delivers a 360-degree view of scientific programs and operations to drive faster, more informed decision-making. |