Qualification of your lab's instrumentation needs to be performed at many stages within the instrument's life cycle, and many industries require qualification at extremely regular intervals. In the high regulated pharmaceutical industry, and research data errors can lead to disastrous outcomes, which is why IQ/OQ/PQ regulations exist. Whether your instrument was just repaired, transported to a new location, or has an upcoming audit, Analytical Measurement Solutions can help with the full spectrum of laboratory equipment qualification services.
Qualifications can be included in our ongoing service contracts and/or in our laboratory asset management offerings. Preparing for an audit? Contact us so we can ensure your labs is staying fully compliant.
Qualifications can incorporate existing manufacturer protocol and/or a client’s existing protocols, and this be customized to fit your intended use in accordance with USP <1058>. Qualifications conducted by an independent outsourced provider, rather than an employee of the company, is important to ensure compliance. Equally important is knowing the mechanics as well as the requirements of USP <1058>.
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) are requested for routine, scheduled qualifications of laboratory systems, and for first time qualification of recently purchased instrumentation.
Qualifications are done routinely, after component replacement or repair, following a facility or instrument move in a GLP/cGMP facility, and when subject to inspection, audit or review.
Installation Qualification, or IQ, is a documented verification process that ensures the system components and support systems have been installed correctly and completely. IQ is performed in accordance with manufacturer and customer requirements, government regulations and industry standards.
Operational Qualification, or OQ, is a documented verification that ensures the system components operate properly in accordance with manufacturer and customer requirements, government regulations, and industry standards. OQ establishes confidence that the components are capable of consistently operating within the established limits and tolerances required by the system they support.
Performance Qualification, or PQ, is the documented collection of activities necessary to demonstrate that and instrument consistently performs according to the specifications defined by the user and is appropriate for the intended use. After the Installation and Operational Qualification has been performed, the instruments combines suitability for its intended use is demonstrated through the Performance Qualification.
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