QUALIFICATION AND VALIDATION
We execute IQ, OQ and PQ qualifications. The scope of each level is always thoroughly discussed with the customer - you present your requirements, we offer solution. Sound testing scope lays the foundation of a successful qualification.
We prepare comprehensive validation documentation including validation protocol (plan) and validation report. If required, we provide VMP (Validation Master Plan), DQ (Design Qualification) or assist to complete RA (Risc Analysis).
WE QUALIFY THE FOLLOWING EQUIPMENT AND SYSTEMS
Clean utilities
- PW - Purified Water
- WFI - Water For Injection
- CS - Clean Steam
- Compressed gasses - air, nitrogen, oxygen
Thermal processes
- Sterilization - sterilizers, heat tunnels
- Sanitation
Process equipment and systems
- Tanks, reactors, pipelines
- SDF manufaturing equipment
- LDF manufacturing equiment
- ... and other
Temperature / humidity controlled equipment
- Warehouses
- Refrigerators, Freezers
- Incubators
- Stability chambers / rooms
Computer systems
- Embedded systems
- Custom made systems
- IT systems
- MES systems
- Electronic batch record systems
Other services
- Validation supervision
- Consultation
- Preparation and revision of validation documentation (VP, VR, VMP, DQ, RA)