From CSV to CSA: Shift to a risk-based approach to improve software quality and FDA compliancetricentis.com 2 © 2023 Tricentis USA Corp. All rights reserved | Computer system validation (CSV) approaches have deviated little since the FDA first released its guidance in 1997. Meanwhile, just about everything else about the way software is built, tested, and released has changed. When it comes to CSV, outdated is a bit of an understatement. That’s not to say the FDA hasn’t evolved its approach to compliance over the last 25 years. THE EVOLUTION OF CSV In 2003, the agency released updated guidance to clarify and expand on the 1997 21 CFR Part 11 regu- lation. This guidance introduced the concept of a risk-based approach, encouraging organizations to tailor the extent of their validation

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