Gamp Category 4 May 2026

In the world of regulated GxP environments (GMP, GLP, GCP), validating software is not optional—it’s a regulatory requirement. The GAMP 5 (Good Automated Manufacturing Practice) framework provides a risk-based approach to software validation. Among its five software categories, Category 4 is the most common, yet frequently misunderstood. What is GAMP Category 4? GAMP Category 4 refers to Configurable Software . These are software products that are not used "out of the box." Instead, they are configured by the user or system integrator to meet specific business processes.