Valicom’s Erik Staley explains how to make your computer system validation projects less complex and more efficient
FDA’s 2025 final guidance on Computer Software Assurance (CSA) translates well for use with drug and biologics environments operating under GLP, GCP, and GMP. CSA’s practical message is to right-size validation and assurance activities: apply greater rigor where system/software failure could plausibly compromise product quality, patient safety, or data integrity, and reduce effort where failure would not.
This paper highlights practical efficiency opportunities enabled by a CSA-aligned approach and points readers to additional methods and supporting resources, including ISPE’s GAMP® 5 2nd Edition and other relevant industry guidance.
Learn in the FREE DOWNLOAD:
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- Why traditional CSV became inefficient
- Why FDA’s CDRH Guidance for Computer Software Assurance (CSA) matters to drug GxP, even though the guidance is device-scoped
- How to apply CSA efficiencies in GLP, GCP, and GMP environments
- How to right-size testing based on risk
- Data integrity guardrails when using CSA techniques
- How to leverage supplier and vendor documentation
- How Valicom assists our industries with CSV/CSA and GxP validation