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When is the qualification of an HPLC system recommended?

  • When reinstalling or relocating
  • At startup
  • After a maintenance or repair
  • As a regular check of the performance of the device
The following qualification steps are common for the qualification of a measuring system:

Installation Qualification (IQ): verifies and documents the correct delivery, condition and installation of the device.

Operational Qualification (OQ): also called functional qualification is a manufacturer-standard test that verifies and documents the correct functioning of a device.
An IQ and an OQ can be performed on a device or a system, system qualifications are more complex.

Performance Verification (PV): checks the performance of an equipment at appropriate intervals to ensure that the quality requirements for the measurement or manufacturing process are met in continuous operation.

Did you know that we have a free IQ document and standardized OQ documents available for you, if you own a KNAUER device? You can use this to perform e.g. an OQ check of the devices according to the manufacturer's specifications yourself. Just contact our support. Don’t forget to mention the device serial numbers in the form’s note field to get the correct OQ documents.

Do you need help with the qualification of your KNAUER devices? You can hire our certified service technicians to carry out the qualification for KNAUER equipment or systems at your site. We also advise you on the design of GMP-compliant performance verification of LC systems for purification. More services such as a Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and material certification are also available.

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