Gamp 5 Software Categories ●

Not all software is created equal. Validating a simple spreadsheet requires a different level of rigor than validating a global Enterprise Resource Planning (ERP) system. Categorization allows you to:

Low to Medium Validation approach: Simplified – focus on user requirements and testing against intended use. gamp 5 software categories

Categorization is not a "one and done" task. If you take a Category 3 product and add a custom script to it, the entire system (or at least that module) effectively becomes Category 5. Always align your validation strategy with the present in the system to ensure patient safety and data integrity. Not all software is created equal

Low (when used as intended) Validation approach: Not validated individually – qualified as part of infrastructure qualification. gamp 5 software categories