Compliance Services

You hear many terms to describe these services such as IQ, OQ, PQ, PV and others.  What do they really mean and what is right for your lab? Let’s start with some definitions for these terms.

 

IQ or Installation Qualification is performed when the instrument is installed at a location.  This may be done at the initial installation when the instrument is purchased or as a reinstallation when an instrument is moved to a new location.  The purpose is to show that the installation met all the manufacturer’s requirements for power, climate and other utilities.

 

OQ or Operational Qualification is often combined with PV or Performance Verification into an OQ/PV testing set.  This set of tests is to prove the instrument is operating to factory specifications. Tests performed include flow rate, linearity, reproducibility and accuracy of operation.  In an HPLC system, the pump flow would be checked for accuracy and consistency (precision), detector response would be checked for linearity and the autosampler would be checked for reproducibility.  Other tests may be added, as required for the specific configuration of that instrument. Test results would then be compared back to factory specifications for the instrument to determine if performance was “within specifications”.

 

PQ or Performance Qualification uses a sample analysis to verify operation of the system.  A test sample is analyzed for both reproducibility and accuracy to determine if the overall performance was consistent with expectations.  TVSS uses the manufacturer’s test samples for Agilent instrument testing to allow traceability to the manufacturer’s checkout procedure for new instruments.  This means performance can be compared from the initial installation to the current PQ of the instrument to determine if changes have occurred.

 

TVSS can provide a full range of compliance services to meet your needs.  As the exact need for your facility may vary, we invite you to call us to discuss these services.  

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