Kinesis Solutions realise how important it is to comply with regulatory bodies such as the FDA, and to ensure that all HPLC equipment is fit for the purpose it was designed for.
Kinesis Solutions therefore, have put together a package of test, which can be carried out in conjunction with a pre-planned maintenance visit or on their own to ensure that all components are within acceptable limits and satisfy regulatory criteria. All our tests are fully traceable and are carried out using strict Standard Operational Procedures (SOPs) and come complete with raw data and certification.
Tests are available for pumps, detectors, autosamplers and column ovens from flowrate verification to autosampler precision.
All qualification tests carried out by Kinesis Solutions are 21 CFR Part 11 compliant.