Commissioning, Qualification & Validation
At Forza Pharma Consulting, we provide comprehensive Commissioning, Qualification, and Validation (CQV) services for life science facilities, utilities, and equipment. Our team brings strong engineering expertise to streamline CQV projects, with extensive experience applying risk-based verification methods in practical, real-world settings. Our approach ensures all key elements for compliance, system sustainability, and local site integration are taken into consideration. Our project strategy ensures effective project team dynamics catered to project needs with strict adherence to schedule.
We manage every phase of the CQV lifecycle—ensuring compliance, efficiency, and confidence in your biopharmaceutical manufacturing solutions.
CQV Lifecycle Expertise
Validation master planning & validation determination
Risk assessments, GAP assessments, trace matrices, and control strategies
FAT, SAT, leveragable commissioning and qualification testing
Design qualification and design verification
Process and cleaning validation
Cycle development and performance qualification
Periodic review, re-qualification, and re-validation
Quality and production analytical instrument qualification
P11 compliance assessment and data integrity assessment
Systems We Support
Process Equipment: upstream, downstream, fill-finish
Facilities & Utilities: WFI, clean steam, HVAC, CTEs
Packaging Equipment: assembly / blister / carton packaging, aerialization / aggregation systems
Automated Systems: DCS, PLC, SCADA, DeltaV
Quality Control Labs: analytical instruments
Enterprise/IT Systems
Spreadsheet Validation
Support Equipment: autoclaves, washers, TCUs
CQV Best Practices
Integrated Commissioning and Qualification tailored to operations / product / facility
CIP and SIP cycle development & cleaning verification
Effective handover of activities from vendor to the client facility
Thermal mapping equipment / facilities and performing cycle development
Timely and effective Incidence and Discrepancy Resolution
Contact Forza Pharma Consulting today to streamline your next CQV project with expert guidance.
