Our Approach
CompliScience Solutions provides regulator-aligned commissioning, qualification, and validation (CQV) support for cGMP facilities, utilities, equipment, manufacturing processes, and analytical test methods.
Effective CQV is not about generating binders of paperwork…it is about demonstrating that facilities, systems, processes, and test methods are fit for their intended use and capable of operating in a controlled, reproducible, and compliant manner.
We help clients translate regulatory expectations and scientific risk into right-sized, defensible CQV programs aligned with FDA, EMA, ICH, EU GMP, and USP expectations.
Our team brings hands-on experience executing real-world CQV programs for cleanrooms, HVAC systems, critical utilities, manufacturing equipment, computerized systems, aseptic processes, and analytical test methods.
We integrate risk-based approaches, Quality by Design (QbD) principles, and lifecycle validation concepts to ensure validation effort is focused where it matters most.
Our support includes:
oCommissioning strategy and execution support
oValidation Master Plan (VMP) development
oRisk-based qualification strategy (FAT/SAT, IQ/OQ/PQ)
oCleanroom qualification and EMPQ
oHVAC and critical utility qualification
oEquipment qualification
oComputer system validation (CSV) and Part 11 readiness
oAseptic process validation and media fill strategy
oAnalytical test method validation
Rather than over-validating low-risk systems or under-validating critical ones, we design CQV programs that are technically sound, inspection-ready, and defensible.
