Gamp - Classification 'link'

Validation for Category 4 is more rigorous. It requires a detailed URS, a configuration specification, and comprehensive testing (IQ, OQ, and PQ) to ensure the configuration correctly reflects the intended business processes. Category 5: Custom Software

This category covers the foundational software upon which other applications run. It includes operating systems, database managers, and middleware. gamp classification

Conversely, applying Category 5 rigor to a standard Category 3 tool (like treating MS Word as a custom application) is a waste of resources. It creates mountains of unnecessary documentation, delays project timelines, and consumes budget that could be spent on actual risk mitigation. Validation for Category 4 is more rigorous