Gamp 5 — Categories !!top!!

At the heart of GAMP 5 are the . These categories help quality and IT teams decide how much validation effort is needed based on the complexity and risk of the software. Why Categories Matter

. This requires a full lifecycle approach, including design specifications, code reviews, unit testing, and rigorous User Acceptance Testing (UAT) . Summary of Validation Efforts GAMP Category Software Type Complexity Validation Rigor Category 1 Infrastructure Low Record version/Install Category 3 Non-Configured (COTS) Medium-Low Verify against URS Category 4 Configured Medium-High Validate configurations Category 5 Custom / Bespoke High Full SDLC & Testing Key Takeaway: Think Risk-First The goal of GAMP 5 is not to create more paperwork, but to ensure gamp 5 categories