SMB Validation

Operation Qualification Protocol

The SMB Validation & Compliance Services Group can develop Operation Qualification Protocols to describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs are manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.

“Equipment manufacturers can also use and execute our protocols as a Dry Run prior to shipping the equipment. This will accomplish two important goals. First, if something is wrong, the equipment manufacturer will discover it while the equipment is still under its full control at its site where all the resources and personnel are readily available to deal with the situation. Second, this will normally result in a shorter implementation time at the customer’s facility thus enabling them to put the equipment into production without undue delays.”