Commissioning, Qualification, and Validation (CQV)
CQV Services
CQV Experience
CQV Experience
- 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
CQV Experience
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