Gamp - Classification

GAMP Classification is not merely a box-ticking exercise; it is a strategic tool for resource management and quality assurance. By accurately categorizing systems into Category 1, 3, 4, or 5, organizations can demonstrate regulatory compliance while optimizing their validation budgets. In an era where data integrity is under intense scrutiny, applying the correct GAMP category ensures that systems are tested to the depth required to ensure safety, efficacy, and quality—no more, and no less.

❌ – Treats all configured software (Cat 4) similarly, but a simple config (e.g., setting a date format) differs vastly from complex logic (e.g., 500 business rules in a LIMS). No sub-category for configuration complexity. gamp classification

⭐⭐⭐⭐ (4/5) — Critical for compliance, yet showing its age in parts. GAMP Classification is not merely a box-ticking exercise;

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 ❌ – Treats all configured software (Cat 4)

A system's category tells you what the software is. A Risk Assessment tells you how critical it is to patient safety and product quality.

It is important to note that GAMP Classification is not the only factor in determining a validation strategy. GAMP 5 advocates for a .