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Operational Qualification

OQ is the term used in pharmaceutical and FDA environment, in ISO/EN/Accreditation environment the term Performance verification (PV) is used.

OQ/PV helps to qualify the analytical system for correct operation in the customers laboratory.

For instruments and software this means

  • Demonstration of fitness for use against URS/DQ in general functional tests
  • Verification of correct operation of the new hardware and software according to approved protocols
  • Audit-ready documentation

 

PSS OQ Services comprise

  • Verification and documentation of the system's ability to meet specified criteria according to a mutually agreed testplan
  • Instrument functional and operational tests
  • Procedures and documentation that meet the requirements of GLP, ISO 9000, and other regulatory agencies
  • optional holistic GPC/SEC test with PSS EasyValid GPC/SEC system suitability test