A risk-based life cycle approach to build in quality and focus validation efforts.

 

  • Validation Planning
  • Equipment & Utility Qualifications (IQ/OQ/PQ)
  • Process Performance Qualification (PPQ)
  • Continued Process Verification
  • Computer & Automated System Validation
    • Support with all life-cycle documentation and SOPs
    • Automated Equipment (URS/Functional Spec/Design Specs/FAT/SAT/IQ/OQ/PQ)
    • Test Systems
    • Monitoring Systems
    • Supply Chain / Temperature Monitoring Systems
    • 21 CFR Part 11
    • GAMP 5
  • Method Validation
  • Cleanroom Validation
    • Particulates (ISO 14644)
    • Environmental (Temperature / Humidity)
  • Stability Chamber Validation
  • Refrigerators / Freezers / ULT Chambers – Reach-in / Walk-in