The intended purpose of Performance Qualification is to demonstrate compliance with all requirements given in the User Requirements Specification document. Performance Qualification should follow on from successful completion of Operational Qualification (OQ) and should include tests designed to verify the satisfactory performance of the equipment or system in the organisations processes. Performance Qualification should be carried out using real process materials and tests intended to demonstrate satisfactory performance over the full range of expected operating conditions.

Prior to Performance qualification; all required methods and Standard Operating Procedures should have been finalised and operator training completed. Also, requirements for Calibration, Preventative Maintenance and Cleaning should have been addressed


funcionamiento (m)
n. functioning, performance, working, operating