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.
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.
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.
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 team1 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?
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.
This week we turn back the clock a couple of years to 2018, when Fairchild et al.published in the journal Frontiers in Public Health their analysis of the challenges of epidemiological data reporting. With the march of COVID-19 today, their analysis and advice holds even more relevant today. In their paper, Fairchild et al. first introduced the state of epidemiological data reporting, particularly on the internet. They then discussed the three challenges that affect such reporting: user interface, data format, and data reporting issues. They concluded with nine clear best practices that should be followed when managing epidemiological data for release to the public. They imagined a scenario of a standardized platform adopted worldwide, "where global data could be easily collected without the challenges we currently face. This would in turn streamline epidemiological and public health analysis, modeling, and informatics, resulting in better public health decision-making capabilities."