Gamp5 - Category

While some argue that modern Agile and DevOps methods are moving away from rigid "category thinking," understanding these categories is still the fastest way to determine how much validation work you actually need to do.

In the world of pharmaceutical, biotech, and medical device manufacturing, compliance isn't just about paperwork—it's about patient safety. For decades, the GAMP (Good Automated Manufacturing Practice) guide, specifically GAMP 5, has been the gold standard for validating computerized systems.

Here is the modern guide to the GAMP 5 categories. Before diving into the numbers, remember the mantra of GAMP 5 (2nd Edition): Critical thinking over template filling.