Qualification and validation are fundamental elements of a quality assurance system. Their purpose is to provide evidence that manufacturing and quality control facilities, equipment, and procedures are adequate for their intended purpose, and that those make sure that the required quality of the medical devices manufactured is met.
With our long-standing experience in facility and equipment qualification, as well as in the validation of production and cleaning processes, we gladly advise and support You in all questions and tasks to be tackled in Your work context.
We not only help You to effectively plan and realize risk-based and GMP-conform qualification and validation. 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 and validation activities
- Support in planning, coordination and realization of qualification and re-qualification tasks as well as process and cleaning validation activities
- Performance of calibrations as required during qualification activities
- Preparation of master SOPs for qualification, process and cleaning validation
- Preparation of a validation master plan
- Compilation of equipment / instrument requirement specifications and User Requirement Specifications (URS)
- 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)
- Training of employees