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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.
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.