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  Stability Tests > Qualification / Calibration and more ... > Qualifizierung



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Qualification

For the approval of pharmaceuticals and providing evidence of stability tests, numerous steps must be taken to ensure that the stability test chambers function correctly, e.g. fluctuations in temperature and humidity remain within the stipulated range and this over extremly long periods of time.
These requirements are continuously confirmed by our extensive Qualification documentation

The entire system qualification comprises:

FATFactory Acceptance Test
DKDCalibration
DQDesign Qualification
IQInstallation Qualification
OQOperation Qualification
PQPerformance Qualification

as well as all the necessary documents, such as circuit diagrams, component lists and certificates, e.g. ISO accreditation, EG conformity declarations or also maintenance recommendations.

Our trained technicians not only carry out on-site qualification on request, but utilize also the extensive measurement and calibration facilities of our accredited DKD laboratory.
      
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