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Our installation qualification, operational qualification, and performance qualification processes verify that a facility, system, or piece of equipment meets all the necessary requirements, specifications, and achieves its intended purpose. Our talented commissioning, qualification and validation (CQV) team ensures that all equipment and systems used in the manufacturing process are appropriately designed, meet the specified requirements, are properly constructed and installed, operate as intended and perform to achieve the defined User Requirements. Our core services include:

  • CQV master plan development
  • Impact, criticality, and risk assessments
  • FAT/SAT management and support
  • IQ/OQ/PQ protocol writing
  • Field execution of protocols
  • Report writing
  • CQV project management
  • Document management and turn-over packages
  • SOP development
  • Calibration and preventive maintenance program development
  • Training

 

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