Process validation
Process validation is an essential and critical element for the safety and functionality of medical devices and laboratory tests
- Process validation is explicitly stipulated in QM systems (DIN EN ISO 9001:2008, DIN EN ISO 13485:2003, GMP, DIN EN ISO 15189:2007), in the guidelines of the German Medical Association (RiliBÄK:2008) and in the German Medical Devices Operator Ordinance (MPBetreibV:2002).
- It includes preparation of documentary confirmation that a process will always create a result or product that conforms to the set requirements.
| Areas of process validation | Includes the | In brief |
| Design Qualification (DQ) | documentary evidence 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 evidence that the commissioned model of the product (device) installed is in line with the intended purpose and the manufacturer's data |
Describes all the steps for installation of a product (device) up to start-up |
| Operational Qualification (OQ) | documentary evidence that the model of the product (device) installed functions in accordance with its specifications | Guarantees the basic functions of a product (device) under the conditions at the installation site and in the work environment |
| Performance Qualification (PQ) | documentary evidence that the product (device) functions when operating under real (routine) conditions in accordance with the regulations and requirements (specifications) | Establishes the repeatable and sustained positive performance of a product (device) in accordance with the specifications under normal use |
| Maintenance Qualification (MQ) |
documentary evidence of regular maintenance. Description of all the measures necessary for cleaning, maintenance and repair | Describes the requirements for maintenance of a product (device) |
SEGO|SOFT
