Auditors will expect to see a number of documents to demonstrate that your GMP Compliance Management Software has been validated. The documentation required spans several phases:
- Planning: In this stage, you must prepare a written validation plan.
- Specification: Here you detail your requirements and conduct design reviews. Required documentation includes User Requirements Specifications (URS), risk analysis, CFR Part 11 compliance analysis and network diagram.
- Test Planning: This is where you document how you’ll test your system. Documentation includes Installment Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ) and Requirements Traceability Matrix (RTM). The User Acceptance Test (UAT) shows that a particular item meets the URS.
- Testing: In this phase, you must perform the required tests, mitigate/resolve any discrepancies and gather your results.
- Review: The final stage of validation involves reviewing your results to demonstrate that your QMS performs as intended. Documentation includes the validation report, which companies often structure similar to the validation plan.
The FDA allows you to combine these documents, as long as all of the required information is complete.
