Instrument qualifications:
For Instrument qualification documentation which is an integral part of Quality Control team, “enviro-x” will provide its qualification documents which will satisfy user requirement for qualification audit.
Apart from normal calibration certificates which is included by default “enviro-x” also issues IQ/OQ/PQ certificates on request.
2.1 Installation Qualification (IQ):
After completion of Installation of an instrument its results are summarised and evaluated in a document called as Installation Qualification.
2.2 Operation Qualification (OQ):
The Operation Qualification OQ is a test process that evaluates the correct functioning of a facility or an appliance. 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.
2.3 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. The appliances and systems are not inspected individually but always as part of the overall or partial process. Even though PQ usually comprises OQ tests under process conditions (e.g. for hot air sterilisers with load), a detailed test plan has to be created based on a comprehensive process description before the validation process is started in any case.