This category covers "off-the-shelf" software that is used exactly as it comes out of the box. You might enter data into it, but you don’t change how the software itself functions.
The key principles of GAMP5 include:
GAMP5 is a set of guidelines for the validation of computerized systems in pharmaceutical manufacturing. The guidelines provide a framework for ensuring that automated systems are designed, installed, and operated to produce consistent and reliable results. gamp5 category
Laboratory instrument software with fixed workflows, standard calculators, or firmware-based controllers. This category covers "off-the-shelf" software that is used
| GAMP Category | Typical Risk | Documentation Effort | Key Activity | | :--- | :--- | :--- | :--- | | | Low | Low (IT controls) | Inventory list | | 3 | Low-Med | Medium | User Acceptance Testing (UAT) | | 4 | High | High | Risk assessment + Config testing | | 5 | Critical | Highest | Code review + Unit testing | The guidelines provide a framework for ensuring that