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Notes on validation,from people who do it.

What changes when the computer does the testing. CSV and CSA in practice, 21 CFR Part 11 and Annex 11 explained, and how the chain from requirement to signed report works on real systems.

Efficient UAT for GxP Systems: Where Merivane.ai Helps
FeaturedWhite paper · PDF

Efficient UAT for GxP Systems: Where Merivane.ai Helps

Regulators ask for confidence proportionate to risk, not a volume of paperwork. Our white paper sets out a risk-based UAT model for Part 11 and Annex 11, and where AI cuts effort without cutting assurance.

Vijay BOct 28, 2026 · 4 min read
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Efficient UAT for GxP Systems: Where Merivane.ai Helps
MethodWhite paper · PDF

Efficient UAT for GxP Systems: Where Merivane.ai Helps

Regulators ask for confidence proportionate to risk, not a volume of paperwork. Our white paper sets out a risk-based UAT model for Part 11 and Annex 11, and where AI cuts effort without cutting assurance.

Oct 28, 20264 min read
From traditional CSV to CSA: what changes when the computer does the testing
Regulation

From traditional CSV to CSA: what changes when the computer does the testing

The FDA's Computer Software Assurance guidance shifts effort from documentation to critical thinking. Here is how an automated validation engine fits that model.

Aug 12, 20266 min read
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