GAMP 5 software categories group software components in GxP computerized systems to help plan an appropriate, risk-based lifecycle approach. The current categories are:
- Category 1 — Infrastructure software, tools, and IT services: for example, operating systems and infrastructure platforms.
- Category 3 — Non-configured products: software used as supplied, without application-specific configuration.
- Category 4 — Configured products: software configured to support defined business processes.
- Category 5 — Custom applications: software developed for specific user requirements.
Category 2 is not used in the current GAMP 5 software classification. Categories 3–5 are a continuum, and a category alone does not determine validation effort. Teams should scale assurance to intended use, system complexity, and risk to product quality, patient safety, and data integrity. See ISPE’s GAMP guidance.