Commissioning, Qualification & Validation (CQV) Services
Trusted CQV consulting for pharmaceutical and biopharma manufacturers nationwide. Our extensive knowledge and proven strategies help you achieve operational readiness and bring life sciences products to market on time and on budget.
Comprehensive Pharmaceutical CQV Excellence
Whether you partner with us for your entire commissioning, qualification and validation project scope or require a more specialized solution, Sequence delivers proven CQV strategies designed for pharmaceutical and biopharma manufacturers.
What sets us apart is our ability to interpret regulatory requirements through a different lens than traditional C&Q. Rather than defaulting to a one-size-fits-all testing approach, we leverage our deep process knowledge and engineering expertise to develop right-sized, risk-based strategies that satisfy compliance while eliminating unnecessary testing and documentation overhead.
Our systematic approach ensures every system, process, and piece of equipment meets FDA, EMA, and global regulatory requirements and performs as intended. From documentation development through final qualification, we provide the GMP expertise needed to maintain compliance and operational excellence.
Combined with our engineering and computer system validation capabilities, Sequence offers a fully integrated quality and compliance consulting solution for life sciences facilities.
Three Core Pharmaceutical CQV Disciplines
Systems & Equipment Qualification
Full lifecycle qualification for pharmaceutical buildings, utilities, production equipment, and GMP controlled environments.
- Buildings & Facilities: HVAC, rooms, water systems, electrical, fire protection, waste management, security
- Clean Utilities: WFI, RO, compressed gases, clean steam
- Dirty Utilities: Water, instrument air, waste systems
- Production Equipment: Manufacturing, packaging, laboratory, cleaning systems, buffer vessels
- Upstream: Bioreactors, fermentation
- Downstream: Chromatography, filtration, formulation, fill/finish (vial, syringe)
- OSD & API: Oral solid dosage and active pharmaceutical ingredient processing systems
- Lab Equipment: UV-Vis, HPLC/UPLC/GC, TOC analyzers, plate readers, microbiology equipment
- Clean Rooms: Particulate/microbial controls, temperature/humidity, air flow patterns
Testing Documentation Development & Execution
Comprehensive pharmaceutical documentation and protocol execution following Good Documentation Practices (GDP) and ALCOA+ principles for regulated life sciences environments.
- User Requirements Specifications (URS)
- Functional and Design Specifications (FS/DS)
- Risk Assessments (FMEA)
- Commissioning Protocols & Checklists (IV/OV)
- IQ/OQ/PQ Protocol Development
- Process, Cleaning & Computer System Validation
- Protocol Execution
- Real-time Data Recording & Deviation Management (paper and electronic)
- Final Report Generation
- Inspection-Ready Package including Traceability Matrices
Process & Method Validation
Validation strategies for critical pharmaceutical processes, analytical methods, and cleaning procedures to ensure consistent product quality and GMP compliance.
- Water Systems: Purified Water (PW), WFI, Clean Steam
- Compressed Air & Gases: Clean compressed air, N₂, O₂, CO₂
- HVAC Systems: Cleanroom AHUs, pressure differentials, HEPA filtration, air change rates
- CIP & Sterilization: CIP, SIP, autoclaves, sterilizing filters, filter integrity testing
- Equipment Validation: Lyophilizers, filling/packaging lines, process equipment
- Analytical Methods: HPLC, GC, UV/Vis, TOC analyzers, pH meters
- Microbial Methods: Sterility testing, endotoxin detection, bioburden testing
- Cleaning Validation: Mixing tanks, reactors, filling lines, pumps, hoses, piping
Proven Life Sciences CQV Strategies & Experience
Our team brings decades of combined experience in commissioning, qualification, and validation for pharmaceutical and biopharma manufacturers. We understand the complexities of GMP environments and regulatory requirements across the Research Triangle and nationwide.
- Regulatory compliance specialists (FDA, EMA, ICH)
- GAMP 5 and ISPE Baseline Guide alignment
- Risk-based validation approaches
- Cross-functional team coordination
- Real-time documentation and deviation management
Sequence CQV Project Lifecycle
We are embedded in every phase of the pharmaceutical project lifecycle — providing CQV leadership, technical oversight, and hands-on execution from initial planning through commercial production.
Planning & Strategy
CQV Master Plans, risk assessments (FMEA), validation strategy, regulatory gap analysis, resource planning
Design & Documentation
URS development, FS/DS, protocol authoring (IQ/OQ/PQ), commissioning checklists (IV/OV), traceability matrices
Construction & Commissioning
Installation verification, startup support, vendor coordination, LOTO walkdowns
Qualification & Validation
Protocol execution, real-time data recording (paper and electronic), deviation management, final reports
Process Validation & Readiness
Process validation (PPQ), cleaning validation, analytical method validation, SOP development, operator training
Turnover & Commercial Production
Inspection-ready packages, audit readiness, system turnover, ongoing monitoring, continued process verification
Ready to Start Your Pharmaceutical CQV Project?
Partner with Sequence for comprehensive commissioning, qualification, and validation consulting that ensures life sciences compliance, operational efficiency, and success — from the Research Triangle to facilities nationwide.
Get Started Today →