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Equipment qualification in the context of quality management is indispensable for a large number of companies. REA VERIFIER offers you customer-specific IQ / OQ certifications, which comply with current regulations, company regulations and Good Manufacturing Practices (GMP).
The Installation Qualification IQ is the documented proof that REA VERIFIER equipment has been delivered and installed in accordance with the requirements of the Design Qualification (DQ). The design qualification has already been carried out before commissioning. The suitability of the equipment system and the supplier has been checked. The order was then created and the equipment supplied. The assembly and installation of the analysis system is carried out by the operator and, where required, by the manufacturer/supplier. Proof of the completeness and functionality of the equipment hardware and software is ensured by functional tests and physical measurements.
IQ test plan: Contains detailed test steps on the tests to be carried out on the respective device in connection with the Installation Qualification IQ as well as the necessary prerequisites and documents to be included.
IQ report: After completion of the Installation Qualification IQ, the results are summarized, evaluated and recorded in an IQ final report. All deviations and the measures taken to eliminate them are documented.
Scope of Installation Qualification IQ:
The Operation Qualification OQ is the commissioning of the testing technology in interaction with equipment hardware and measurement methods, including the proof that all customer specifications are available and covered by the device configuration. The user determines who is in charge of the equipment technology. Training of the operating staff is carried out by the user on his own responsibility, externally by the supplier or both. Operation Qualification can only be carried out after successful Installation Qualification IQ.
OQ test plan: Contains detailed test steps on the tests to be carried out on the respective device in connection with the Operation Qualification IQ as well as the necessary prerequisites and documents to be included.
OQ report: After completion of the Operation Qualification OQ, the results are summarized, evaluated and recorded in an OQ final report. All deviations and the measures taken to eliminate them are documented.
Scope of Operation Qualification OQ:
The Performance Qualification describes the regular testing of the device function during routine operation. Therefore, a monitoring strategy is defined to ensure the functionality of the analyzer system. This includes the execution and documentation of regular checks of measurement accuracy in the sense of test equipment monitoring (calibration). The test system is adjusted according to the manufacturer's specifications. The test data must be recorded as documented proof. Regular preventive maintenance work is carried out by the user and the manufacturer arranges for maintenance to be carried out as required. The user must check the validity of the calibration card and check whether it is damaged.
Scope of Performance Qualification PQ:
For further information please contact us: info(at)rea-verifier.de
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Your REA Team