GAMP 5
ISPE's good practice guide for GxP computerised systems. Source of the software categories and the V-model everyone sketches on whiteboards.
GAMP 5 is not a regulation; it is the industry's shared playbook for building and validating computerised systems, maintained by ISPE. Its software categories sort systems by how much of their behavior is yours to prove, and its lifecycle model maps specification to verification.
The 2022 second edition leaned hard into critical thinking, agile compatibility and supplier leverage, aligning the guide with FDA's CSA direction. If your validation SOP still reads like 2008, the second edition is the gentlest available modernization argument.
Go deeper
All CSVCSV/Jun 2, 2026/8 min
CSA is not the end of CSV. It is CSV finally done right.
FDA's Computer Software Assurance guidance was read by half the industry as permission to stop validating. The other half read it correctly.
CSV/May 21, 2026/7 min
The GAMP 5 software categories, explained like a human
Category 3, 4 or 5 decides how much validation work you are signing up for. Here is how to call it correctly, with a tool that does the asking.