A solid risk management is forming the basis for all qualification stages by which the necessary qualification measures are focussed. We deliver you an adequate risk management for all qualification measures and support you in the integration into your quality management.
We provide comprehensive validation services for manufacturers and distributors of pharmaceutical, biotechnological and veterinary products, manufacturers of pharmaceutical, biotechnological and medical equipment, laboratories, health care institutions, food producers, manufacturers of electronic components.
The next thing to consider when planning the process of qualification and validation is the importance of cooperation of several different specialists: technologists, engineers, metrologists, and others. Our companies form a group of specialists in different fields for specific tasks. Specialists from the formed groups develop protocols, perform tests and develop qualification and validation reports. They are managed by the company's specialists with great experience in this field.
Our services for you
- Conceptual design and advice for risk-based qualification of process setups and equipment
- Structuring the qualification activities (e.g. by means of a qualification master plan)
- Time and resource planning
- Creating qualification documents
- Performing qualification tests
All validation activities are carefully planned. The guiding document on qualification and validation of the object is the Validation Master Plan. Within the scope of this document Risk Analysis is performed.
We provide services for all stages of qualification:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operation Qualification (OQ)
- Performance Qualification (PQ)