As the Life Sciences adapt to manufacturing amidst Covid-19, the FDA is also updating guidelines for computer system validation. So, what does this mean for your organization? Diane Gleinser and Sandy Hedberg discuss the intricacies of the new guidance, and how you will need to adapt when it comes to showing evidence that the computer systems you're using comply with the predicate rules.   Diane has an impressive background in the Life Sciences, and brings her experience, knowledge, and her certification in medical device and pharmaceutical law to USDM and the industry as a whole. Diane Gleisner , VP Life Science Services and Solutions Sandy Hedberg QA/RA Manager, Cloud Assurance at USDM Life Sciences USDM Life Sciences What we talked about: Changes coming to Computer System Validation The FDA’s urging company’s to utilize automation in their manufacturing process  CSA approach vs CSV  approach Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website.