Gamp 5 — Ispe

The original GAMP 5 was written with the traditional "Waterfall" development model in mind. The Second Edition explicitly addresses Agile and iterative development methods, acknowledging that modern software development moves fast and validation must adapt to short sprints rather than long phases.

Note: The Second Edition encourages reclassifying some Category 5 (custom) as Category 4 if using standard platforms with configuration. gamp 5 ispe