A key feature of GAMP 5 is system categorization, which helps determine the level of validation effort required.
| Category | Description | Validation Strategy | | :--- | :--- | :--- | | | Infrastructure Software (OS, Database engines, Network components). | Verify installation; managed by IT procedures. | | Category 3 | Non-Configured Products (Off-the-shelf software used "out of the box," e.g., MS Word, standard calculators). | Focus on User Requirements and "black box" testing. No code review needed. | | Category 4 | Configured Products (Off-the-shelf software configured for specific use, e.g., LIMS, SCADA, ERP). | Configure parameters; validate configuration and workflows. Most common category for lab/manufacturing systems. | | Category 5 | Custom Applications (Custom coded software). | Full lifecycle validation, including code review and unit testing. Highest risk and cost. | gamp guide for validation of automated systems
Validation doesn't end at Go-Live.
