Process validation is an essential and critical element for the security and correct functioning of medical devices and laboratory trials.
| Areas of process validation | Includes the | In a nutshell |
|---|---|---|
| Design Qualification (DQ) | dokumentierten Nachweis, dass das Produkt (Gerät) entsprechend den geplanten Anforderungen / Spezifikationen für den beabsichtigten Verwendungszweck geeignet istDefiniert die Kriterien für eine Kaufentscheidung | |
| 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 |
| Functional qualification / 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 environmentr |
| 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, servicing, repair qualification / Maintenance Qualification (MQ) | documentary confirmation of regular main-tenance. Description of all the necessary cleaning, maintenance and servicing measuresdocumentary confirmation of regular main-tenance. Description of all the necessary cleaning, maintenance and servicing measures | Beschreibt den Description of the necessary efforts for maintenance of the product (device) |
