CQV Services
Commissioning, Qualification & Validation
Our CQV Services ensure that your facilities, utilities, equipment, and critical systems are commissioned, qualified, and validated to meet EU GMP, US FDA, and Indian GMP / CDSCO requirements. From design specification through performance qualification, we help you achieve reliable, regulatorycompliant operations.
What We Do
- Development of CQV Plan (including DQ, IQ, OQ, PQ) consistent with GAMP5, Annex 11, US GMP, Indian GMP requirements
- Commissioning of utilities, clean rooms, HVAC, environmental controls per international and local standards
- Qualification of equipment, instruments, process systems, validation of facility utilities (e.g., water, steam, gas)
- Thermal validation and mapping (temperature, humidity) especially for cold chain, storage, clean zones
- Automation systems qualification (PLC, SCADA, DCS, MES) all under controlled conditions per Annex 11 / 21 CFR
- Calibration and performance verification of equipment per regulatory schedule
- Vendor / contractor oversight including FAT / SAT and supplier qualification
- Greenfield and brownfield project CQV, retrofits, expansions
- Documentation readiness: protocol, summary reports, regulatory signoff
