Synbiosis™ ChromaZona Instrument Validation Procedures
ChromaZona Instrument Validation Procedures take the user through each step in the verification of a Synbiosis™ system regulatory compliances and standard operational procedures (SOP). These simple procedures allow the user to verify that a system meets defined installation, operational, and performance quality specifications.
Manufacturer: Synbiosis™ IQOQCH
- Installation Qualification (IQ): 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): Establishes if the system meets all the operation and functionality specifications. An operational test is also included at this stage.
- Performance Qualification (PQ): Establishes 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.
- Documentation: 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.
|Installation and Operational Qualification|
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