Gamp 5 Category 3 ((exclusive)) May 2026

In the GAMP 5 (Good Automated Manufacturing Practice) framework, software is categorized based on its complexity and risk to patient safety, product quality, and data integrity. Category 3 is defined as Non-Configured Software . Definition Category 3 software is off-the-shelf commercial software that is used for a regulated process but cannot be configured to meet specific business workflows. It is typically run with standard, out-of-the-box settings.