Commissioning / Qualification / Validation Support
Our Approach
CompliScience Solutions provides regulator-aligned commissioning, qualification, and validation (CQV) support across facilities, utilities, equipment, manufacturing processes, and analytical methods.
Effective CQV is not about generating paperwork—it’s about demonstrating that systems are fit for their intended use and capable of operating in a controlled, reproducible, and compliant manner. We translate regulatory expectations and scientific risk into right-sized, defensible CQV programs aligned with FDA, EMA, ICH, EU GMP, and USP guidance.
With hands-on experience executing real-world CQV programs, we apply risk-based approaches, Quality by Design (QbD), and lifecycle validation to focus effort where it matters most—delivering inspection-ready systems without unnecessary burden.
CQV Support
Commissioning strategy and execution support
Validation Master Plan (VMP) development
Risk-based qualification strategy (FAT/SAT, DQ/IQ/OQ/PQ)
Cleanroom qualification and EMPQ
HVAC and critical utility qualification
Equipment qualification
Computer system validation (CSV) and Part 11 readiness
Aseptic process validation and media fill strategy
Analytical test method validation
