General: The Risk Assessment is a structured process for analyzing and evaluating potential failures of the equipment following the FMEA method (Failure mode and effects analysis) to gain the greatest possible product safety.

Project-related: Starting with an equipment Risk Assessment, the qualification project gets its direction and scope. This approach allows you to concentrate on GMP-relevant issues of the equipment according to common standard recommendation.

General: The FDS is a detailed description of functions and features, data integrity and software adapted to the latest authorities’ requirements.

Project-related: FDS is generated with Risk Assessment.

General: IQ/OQ is documented evidence that installation and functions comply with the equipment specifications.

Project-related: To complete the qualification, you receive an IQ/OQ document based on the recommendations of the GMP guide published by GMP-Verlag Peither AG and Annex 15 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use.