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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 moving from computer system validation (CSV) to computer software assurance (CSA) is to reset expectations in the life sciences industry and on using 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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