Qualification

Qualification: "argumentation that pieces of equipment work correctly and effectively result in the expected performances. The term “validation” sometimes is extended by the concept of the qualification.”
EU-GMP-guideline, definitions

Qualification supplies the documented confirmation, that the equipment is designed and works as it should:
Qualification → related to equipment

Validation supplies the documented confirmation, that the processes chosen reliably and reproducible lead to the products of the desired quality and security:
Validation   → related to process

We follow the current GMP recommendations and guidelines and consider the current requirements according the GAMP and FDA for our qualification work. You can accompany Factory Acceptance Tests (FAT) for all our products, which can be carried out at our company in Wangen.

We support our customers in all steps of the successful qualification of our installations:

  • Construction of the Traceability Matrix
  • Construction of the qualification test plans for all steps of the qualification
  • Carrying out / support of the design qualification (DQ)
  • Carrying out / support of the installation qualification (IQ)
  • Carrying out / support of the operational qualification (OQ)
  • Carrying out / support of the performance qualification (PQ)

 

 
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