Level 3 Qualification Documentation and Validation Plan

Vimachem Level 3

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.