We support pharmaceutical, biotechnology and medical device facilities operating within regulated GMP and GxP environments, helping clients achieve compliance, inspection readiness and reliable operational performance.
Our commissioning, qualification and validation (CQV) services for life sciences facilities:
We provide:
- ASTM E2500 alignment reviews
- User requirements specifications (URS)
- Design qualification (DQ)
- Factory and site acceptance testing (FAT/SAT)
- Installation, operational and performance qualification (IQ/OQ/PQ)
- Process validation (PV)
- Computer system validation (CSV)
- Cleaning validation
- Cleanroom qualification
- Risk assessments
- Material and personnel flow validation
- Vendor qualification audits
- GMP readiness support

