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