Gamp 5 Category 3 Jun 2026

The GAMP 5 lifecycle model (Planning → Specification → Build → Test → Release → Operation → Retirement) applies, but is replaced by Configuration . The major activities are illustrated below:

If you have to write a "Configuration Specification" document to explain how the system was set up, it is likely Category 4, not Category 3. Best Practices for Compliance gamp 5 category 3

You use built-in tools to change the workflow . For example, if you configure a Laboratory Information Management System (LIMS) to follow a specific multi-step approval routing, it has graduated to Category 4. The GAMP 5 lifecycle model (Planning → Specification