The success of a GMP cleanroom design is dependent on a clear and concise User Requirement Specification (URS) to take through a successful Design Qualification.
Design Qualification (DQ) is the documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose.
In the DQ process, we will go through your URS line by line and prove how each requirement is met. This could be through design drawings, by technical data sheets and meeting regulatory rules and guidance.
Then, at a DQ execution meeting, we will confirm with your key stakeholders, that all URS requirements are met and if not, raise any nonconformances against the URS. We work to close any nonconformances in a timely manner, to allow unconditional approval of the DQ.