Level 3 Qualification Documentation and Validation Plan
Vimachem conforming with the GAMP5 risk-based methodology offers a complete validation plan consisting of:
- Initial System Risk Assessment (ISRA)
- User Requirements Specification (URS)
- Validation Plan (VP)
- Test Cases
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Functional Risk Assessment
- Test Report (executed Test Cases)
- Traceability Matrix (TM)
- Validation Report (VR)
- SOP/Technical document(s) for the use of the VIMACHEM Level 3 Serialization Site Management (SSM) system.
- User manual.