PURPOSE DQ is to verify that the system has been designed as specified in the URS (User Requirement Specification), FDS (Functional Design Specification) and relevant equipment specifications satisfying all GMP requirements. For hardware and software of the control system, verification data will be collected to prove that the system has been designed in accordance with the URS and FDS including the requirements of 21 CFR Part 11. As DQ is the final step to formally review and document the proper design of the system, the protocol must enable the reviewers to verify that all quality-critical attributes and essential technical attributes of the system have been incorporated in the design. When the DQ report is approved, the system is ready for fabrication and construction.