Approach
Auditors do not read walls, they read documents. Our validation cell produces user requirement specifications, design and installation qualification protocols, operational and performance qualification records, and calibration certificates that stand up to WHO-GMP, USFDA, and EU-GMP inspections. We also retrofit older facilities into audit-ready shape.
Where we add value
- Documentation:
- URS, DQ, IQ, OQ, PQ & Validation with Documentation
- Validation:
- Testing & Commissioning
- Air Balancing (Airflow Velocity)
- Integrated Test (HEPA)
- Air Particle Counting
- Pressure Difference
- Recovery
- Temperature & Humidity
What you receive
Validation Master Plan
IQ/OQ/PQ Protocols
Calibration Certificates
Audit Support