PROCESS VALIDATION
Process validation is an essential and critical element for the security and correct functioning of medical devices and laboratory trials.
- Process validation is explicitly required in QM systems (DIN EN ISO 9001, DIN EN ISO 13485, GMP, DIN EN ISO 15189),
in the guidelines of the German Medical Association (RiliBÄK) and in the German Medical Devices Operator Ordinance (MPBetreibV). - It includes preparation of documentary confirmation that a process will always create a result or product which conforms to the set requirements.
| Bereiche der Prozessvalidierung | Beinhaltet den | In kurzen Worten |
|---|---|---|
| Design Qualification (DQ) | documentary confirmation that the product (device) is suitable for the intended use in accordance with the planned requirements/specifications | Defines the criteria for a purchase decision |
| Installation Qualification (IQ) |
documentary confirmation that the version of the product (device) specified in the job and installed corresponds to the intended use and manufacturer’s specifications | Describes all the installation steps for installing the product (device) and commissioning it |
| Operational Qualification (OQ) | documentary confirmation that the version of the product (device) installed functions in accordance with its specifications | Ensures the basic functioning of the product (device) under the conditions and the place it is installed and in the working environment |
| Performance Qualification (PQ) | documentary confirmation that the product (device) functions in accordance with the regulations and in compliance with the requirements (specifications) when operated under real (routine) conditions | Confirms the reproducible and permanently positive performance of a product (device) in accordance with the specifications when used under normal circumstances |
| Maintenance Qualification (MQ) |
documentary confirmation of regular main-tenance. Description of all the necessary cleaning, maintenance and servicing measures | Description of the necessary efforts for maintenance of the product (device) |