Considering CSA? Here’s what you need to know

The U.S. Food and Drug Administration (FDA) has long encouraged a risk-based approach for software that focuses on assurance, not validation. CSA is a framework identified by the FDA that meets current CSV regulation.

The purpose of adopting the computer software assurance (CSA) methodology is to reset expectations in the life sciences industry and to use technology to drive information analytics. Instead of spending 80% of your time documenting and only 20% of your time testing, the CSA methodology flips it so that 80% of your time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of your time is spent documenting.

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On-Demand Event Sessions

USDM hosted its first virtual event, Forward-Thinking GxP Compliance & Process Optimization, with an all-star lineup of life sciences thought leaders. The event addressed various stages of cloud compliance maturity. Whether you are getting startedgetting better, or getting ahead, this discussion will provide guidance for your cloud transformation journey.

Learn more about this topic in our session replay, FDA Perspectives on Cloud Technologies.

Here are links to the other session replays and companion white papers:

Session 1 video: Your Compliance and Technology Today
Companion white paper: Top 5 Opportunities to Improve Compliance Maturity

Session 2 video: Managing Your Regulated Cloud Technology
Companion white paper: Why You Should Consider Outsourcing Your Cloud Vendor Qualification

Session 4 video: Extracting Value from Your Cloud Data and Processes
Companion white paper: Google Cloud Platform for Life Sciences and Health Technology


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