Qualifications

The qualifications are performed according to the good practice guidelines and are a documented proof that the produced equipment or process system is appropriate & ready for the intended use and according to the user’s requirements.

The activities of the department refer to the IQ/OQ testing within the FAT and SAT tests as well as the calibrations and training of users after the SAT testing is completed.

References
Wacker
MSD
Sandoz
Lonza
GlaxoSmithKline
Novartis
Roche
CSL Behring
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