Lab Equipment Qualification Services
FSG can perform onsite lab equipment IQ/OQ/PQ to adhere to your industry’s compliance requirements.
Qualification of your lab’s instrumentation needs to happen at many stages within the instrument’s life cycle, and many industries require qualification at extremely regular intervals. In the highly-regulated pharmaceutical industry, any 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, FSG can help with the full spectrum of lab equipment qualification services.
Installation Qualification, or IQ, is a well-documented validation process that ensures the proper installation and configuration of your lab instrumentation (based upon a manufacturer-approved list, along with government regulations, customer requirements, and more). This can include checking the location of the instrument in the laboratory, making sure the instrumentation has an appropriate power supply, verifying proper software installation, checking peripheral connections, recording calibration dates, and much more.
Operational Qualification, or OQ, is also common when it comes to lab instrumentation quality assurance. This step involves testing the instrument to make sure it functions as specified — the service engineer is normally referencing operating ranges that have been documented by the original equipment manufacturer (OEM). In addition to referencing the OEM listed operating ranges, one must also adhere to the lab’s unique requirements, industry-driven standards, and government regulations. All outcomes are properly documented with notes and will include test results for items such as leveling, fluctuation, repeatability, deviation reports, calibration certificates, performance reports, and more.
Performance Qualification is about addressing instrumentation performance within the manufacturer’s documented ranges in “actual” conditions. For PQ to be implemented, a detailed test plan will be created — FSG assembles a collected group of testing activities that will ensure consistent performance for the instrument’s intended use in the laboratory. Once IQ and OQ have been implemented, Performance Qualification is then done at regular intervals to ensure accurate, reproducible results.