GAMP 5

GAMP 5 – “A Risk-Based Approach to Compliant GxP Computerized Systems” – is ISPE’s industry guide for computerized system validation: published in 2008, since 2022 in its 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 final CSA guidance (2025) added a reference to the Second Edition. QFINITY helped create the Second Edition.