PURPOSE
OQ is to verify that the system operates as specified in the design, satisfying all functional requirements. This protocol will enable the reviewers to verify that all functional testing of the quality critical equipment and components including the requirements of 21 CFR Part 11 is performed and the verification data are collected and attached to this OQ report. OQ is the final step to formally audit and document proper operation of the system. All functional testing for the system must have been completed in coordination with the engineering department and equipment suppliers prior to this OQ test through FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). Some activities of FAT and SAT can be integrated into OQ upon approval of the validation committee. When the OQ report is approved, the system is ready for the execution of PQ.