Synbiosis’s IQ/OQ/PQ procedures take the user through each step in the verification of a Synbiosis system in meeting the demands of the laboratory, regulatory compliances and standard operational procedures (SOP).
- Installation Qualification (IQ)
This verifies that when a system is unpacked it conforms with all purchasing, shipping and unpacking documents. Once this procedure has been followed the system is then ready for the operational check process.
- Operational Qualification (OQ)
This procedure establishes if the system meets all the operation and functionality specifications. An operational test is also included at this stage.
- Performance Qualification (PQ)
A performance check will establish if the system meets the specification for the nature of the purpose it was intended for. This is verified by using a simple target to establish if the system can meet performance criteria.
Each set of IQ/OQ/PQ documents contains a complete set of procedures and checklists for following the verification steps. Included with each ‘pack’ is a simple calibration device (target image) so that the performance of the system can be checked against the PQ requirements. Each set of documents is unique to a particular system and has to be ordered with the system itself. The document pack has full instructions for use and implementation.
- Who does this?
Customer – typically a customer can perform these tests by themselves. Their own internal QC department will be familiar with these processes.
- Synbiosis or its distributors
Trained Synbiosis personnel or trained distributors can also perform the IQ/OQ/PQ procedures, normally at a nominal charge.