Gamp4 Jun 2026

It shifted focus from strictly "manufacturing" to all systems that could impact patient safety, product quality, and data integrity.

The system is built and checked against those requirements. It shifted focus from strictly "manufacturing" to all

GAMP 4 introduced the concept of categorizing software from Category 1 (Operating systems) to Category 5 (Custom/Bespoke applications). This was revolutionary. It explicitly stated that a spreadsheet (Category 3) does not need the same validation rigor as a custom manufacturing execution system (Category 5). It shifted focus from strictly "manufacturing" to all