Where well and professionally done, qualification greatly helps to avoid bad equipment purchases and to prevent aggravating surprises when commissioning.
Because of our long-standing experience in the qualification of equipment and facilities, we are happy to be at Your service concerning any questions and problems in this area.
We not only help You to effectively plan and realize risk-based and GMP-conform qualification. We also support You in preparing straightforward, concise and comprehensive documentation that will be well presentable in inspections and audits.
Our services comprise:
- Risk analysis according ICH Q9 (EU GMP guidelines part III) for identification and definition of required qualification activities
- Preparation of User Requirement Specifications (URS), specification requirements and functional specifications
- Acceptance test of individual equipment components at the manufacturer (Factory Acceptance Test or FAT)
- Acceptance test of equipment components on site (Site Acceptance Test or SAT)
- Support in planning, coordination and realization of qualification and re-qualification tasks
- Performance of calibration as required during qualification activities
- Preparation of master SOPs for qualification of facilities and equipment
- Preparation of comprehensive yet concise qualification documentation
- Training of employees