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Linxis Group

The DIOSNA glossary


Technological terms in an overview

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Qualification


The process of qualification and validation should prove and document that:
1) The devices, the technical equipment and the processes were designed in accordance with the requirements of the GMP regulations (DQ).
2) The devices and the equipment were manufactured and installed in a way that they comply with their planned specification. This includes the installation qualification (IQ).
3) The facilities and equipment works in accordance with their planned specifications. This includes the operational qualification (OQ).
4) The facilities and equipment reproducibly and permanently provide the specified output. This includes the performance qualification (PQ).
5) The computer-based systems (e.g. machines) are suitable for control, regulation or documentation. This includes the computer validation (CV).

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