Understanding the distinction between configuration and customization is critical.
GAMP Category 4 software represents the most common and arguably most misunderstood category in computerized system validation. The original GAMP 4 paper-based model provided a foundation, but it is insufficient for today’s complex, connected, and frequently updated systems. gamp 4 category
They revalidated by implementing a risk-based parameter classification (Critical, Major, Minor) and added automated configuration drift detection. and frequently updated systems.
| Feature | GAMP Category 4 (Configured) | GAMP Category 5 (Custom/Bespoke) | | :--- | :--- | :--- | | | None (no source code changes) | Yes (new code written) | | Configuration | Parameter setting, tables, workflows | Not applicable or minimal | | Supplier role | Provide standard product + config tools | Provide development services | | Validation risk | Medium (focused on correct config) | High (requires unit/integration testing) | | Reusability of evidence | High (supplier documentation) | Low (project-specific) | gamp 4 category