This requires the full lifecycle . Since the code is unique, you must perform design reviews, code reviews, and comprehensive testing (Unit, Integration, and System testing). The burden of proof is on you to show the logic is sound. How to Choose the Right Category
You do not "validate" the software itself. Instead, you verify installation and maintain version control. Documentation is typically limited to an inventory list and proof of installation/patch management. Category 2: (Discontinued) gamp 5 software categories
Microsoft Excel (without complex macros). This requires the full lifecycle
Understanding GAMP 5 Software Categories: A Practical Guide If you work in a regulated industry like pharmaceuticals or medical devices, you’ve likely encountered (Good Automated Manufacturing Practice, 5th Edition). Produced by ISPE, it is the "gold standard" framework for ensuring that computerized systems are fit for their intended use and compliant with regulations like FDA 21 CFR Part 11. How to Choose the Right Category You do
GAMP 5 breaks software down into four primary categories (with a recent shift toward a new fifth one).