GAMP 5

GAMP 5 – “A Risk-Based Approach to Compliant GxP Computerized Systems” – is ISPE’s industry guide to the validation of computerized systems: published in 2008, and available since 2022 in the Second Edition, which strengthens critical thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements – GAMP shows a proven way to meet them. The FDA has pointed to GAMP for orientation for more than two decades: in 2003, its Part 11 guidance named the GAMP 4 Guide as an industry reference for validation; the CSA guidance added a reference to the Second Edition with its 02/2026 revision. QFINITY helped create the Second Edition.