PURPOSE IQ is to verify that the system has been installed as specified in the design, satisfying all process, utility and environment requirements. For hardware and software of the control system, verification data will be collected to prove that the proper control system has been installed as specified in the design including the requirements of 21 CFR Part 11. As IQ is the final step to formally audit and document proper installation of the system, this protocol should enable the reviewers to verify proper installation of all quality-critical components of the system. Prior to this IQ, all installation inspections and functional testing for the system must have been completed in coordination with the engineering department, construction companies and equipment suppliers through FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). Some activities of FAT and SAT can be integrated into IQ upon approval of the validation committee. When the IQ report is approved, the system is ready for the execution of OQ.