Machine and system qualification
Precisely documented proof of performance
All plants, machines, control concepts, and systems must be qualified. This short and simple word involves an enormous amount of work and high levels of expertise.
Qualification is documented proof that a technical system is properly constructed and installed in accordance with the contractually agreed requirements and functions in precisely the manner initially specified by the user.
Qualification as an aspect of validation activities
PIA provides system qualification as a service for projects/orders that are operated in regulated environments. In the qualification process, we run checks on all order-specific items, items specified by the customer in the URS or in the course of the FMEA, and items identified and rated as critical in the risk-based approach. The FMEA is drawn up by PIA in collaboration with the customer within the framework of the project implementation and is followed by the compilation of DQ, IQ, and OQ requirements. Following approval of the documentation on the part of the customer, the tests are conducted on the system or systems. The tests conducted are evaluated in the IQ and OQ report together with the customer, and the system qualification process is concluded. PIA also offers assistance with PQ at the customer’s premises.
Machine and facility qualification
DQ, IQ, OQ, PQ
The suitability test described in the regulations is divided into four qualification phases and also includes facility-specific documentation.
Design Qualification (DQ)
The design qualification provides documented proof that the specification has been prepared in accordance with the requirements of the intended use.
Installation Qualification (IQ)
The IQ provides documented proof that the facility has been installed in accordance with the predetermined design specifications.
Operational Qualification (OQ)
The OQ provides documented proof that the function of the equipment meets the predefined specifications.
Performance Qualification (PQ)
The performance or production qualification provides documented proof that under production conditions, the manufacturing process continuously produces a product that meets its predetermined specifications.