IQ, OQ, PQ Equipment Qualification
For many businesses, equipment qualification in the context of quality management or validation is a must-have requirement. Apart from the calibration certificate, which is included by default, Memmert USA also performs qualification services if required for your validation.
Installation Qualification IQ
The Installation Qualification IQ is the documented proof that facilities and equipment have been delivered and installed in accordance with the requirements and statutory safety regulations stipulated in the design qualification. The documentation for an Installation Qualification normally consists of:
IQ test plan: detailed information of the tests to be performed on the respective equipment in the context of the Installation Qualification.
IQ report: after completion of the Installation Qualification IQ, the results are summarized, evaluated and compiled in an IQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new IQ report.
Operation Qualification OQ
The Operation Qualification OQ is a test process that evaluates the correct functioning of the equipment. During the Operation Qualification OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. The Operation Qualification OQ may only be performed after a successfully completed Installation Qualification IQ. The documentation for an Operation Qualification normally consists of:
OQ test plan: Contains detailed information of the tests to be performed on the respective equipment in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.
OQ report: After completion of the Operation Qualification OQ, the results are summarized, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.
Performance Qualification PQ
Performance qualification PQ of laboratory equipment is an important component of the validation of the entire production process over a certain period of time and for a specific product. Its purpose is to verify and document that the appliances and systems are working reproducibly within the entire specified working range and limits. Making sure your Memmert equipment is in tip top condition and performing to specification has never been easier. Contact Memmert USA's After Sales Department for more information.