Level 3 Qualification Documentation and Validation Plan

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.

Interest request