Gamp 5 | Category

| Feature | Description | |--------|-------------| | | When user selects a GAMP category, the system auto-hides/requires validation steps. | | Risk-based test effort | Category 5 = full regression; Category 3 = sanity test only. | | Document auto-generation | Generates Validation Plan, Trace Matrix, and Report tailored to category. | | Category change audit | If a system changes from Cat 4 → 5, triggers a revalidation and gap analysis. | | GAMP 5 Decision Tree | Interactive wizard to determine correct category before assignment. | | Supplier classification | Links supplier type (e.g., bespoke dev, COTS vendor) to GAMP category. | | Regulatory report filter | Filter validation packages by GAMP category for inspector review. |