Commissioning, Qualification, and Validation (CQV)

CQV Services


  • Startup and Commissioning support of biological and pharmaceutical manufacturing facilities 
  • Commissioning and qualification of processes and facilities to ensure compliance and approval to meet design specification 
  • Facilities, HVAC, Clean Utilities and Plant Utility System C&Q Support 
  • Process and Process Support Equipment C&Q 
  • Aseptic Equipment C&Q 
  • Control Systems C&Q (BMS, PLC based, DCS) 
  • Cleaning Validation
  • Process Validation
  • Coordination and acting as liaison for project between the owner, design, commissioning, startup, validation, and the various owner groups (e.g. manufacturing engineering, maintenance, and quality)

CQV Experience


  • Startup, Commissioning, Qualification, and Validation Project Management 
  • 21CFR Compliance 
  • ASTM E-2500 Risk Based Approach 
  • ISPE Commissioning & Qualification Guidelines 
  • Validation Program Management 
  • Process Validation 
  • Cleaning Validation 
  • Facility Qualification 
  • Equipment Qualification (IQ, OQ, PQ) 
  • Critical Utility Qualification (IQ, OQ, PQ) 
  • Automated Systems Validation 
  • Process Technology Transfers 
  • Analytical Method Validation and Stability Program 
  • Decommissioning