Verifies the software is installed correctly.

Defines the system must do, tailored to the specific business process. 2. Supplier Assessment & Audit

When executed correctly, Category 4 validation delivers high confidence at a lower cost than custom software—but only if the organization recognizes that configuration is not "just settings" but a core element of product and patient safety.

A document that links user requirements (URS) to functional specifications (FS) and finally to test scripts to ensure all requirements are tested. GAMP 4 Category 4 vs. Category 5

While GAMP 4 prescribed a rigid V-model, GAMP 5 (Second Edition) recommends a streamlined but rigorous process tailored to configuration risk.

They revalidated by implementing a risk-based parameter classification (Critical, Major, Minor) and added automated configuration drift detection.