The technical breakdown of how the system will meet your URS. Testing Protocols (IQ/OQ/PQ): IQ (Installation): Is it plugged in and installed right? OQ (Operational): Does it work as intended? PQ (Performance): Does it work for your specific process?
The "who, what, and when." This sets the scope and defines your risk management strategy. GAMP Validation Documentation Templates
The "golden thread" that proves every requirement in your URS has been tested. The technical breakdown of how the system will meet your URS
Good templates are pre-mapped to GAMP 5’s risk-based approach. The "Must-Have" List of Templates GAMP Validation Documentation Templates
Every system follows the same logic, making it easier for quality teams to review.
