Services

Generation of User Requirement Specifications (URS), perform Design Qualification (DQ) and Validation Reviews

Test protocols covering Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Re-qualification (RQ)

Detailed validation reports that contain all of the real-time data generated as well as a concise summary and clear conclusion

Documents in PEV format or customised to suit specific client requirements



  • Autoclaves

  • Cold Store and Stability Rooms

  • Fermenter and Process Vessels

  • Fridges and Freezers

  • Incubators

  • Cryogenic Storage

  • Unidirectional Airflow Stations




  • Blow Fill Seal Machines

  • Dry Heat Ovens and Tunnels

  • Freeze Dryers

  • HVAC and Clean Rooms

  • Isolators

  • Microbiological Safety Cabinets

  • Utilities




PEV are also able to perform the qualification of clean steam generation and distribution systems, water, air and gas systems.