At ViP, we see DQ performing the same function as a Compliance Review except that, being a formal step in the validation process, it will be open to regulatory scrutiny. They both verify that a proposed design solution will satisfy the User Requirement Specification (URS).

Neither the FDA nor EMEA demands DQ as part of a validation exercise, but, without this step, no qualification would be required until IQ stage, i.e. when installation is complete, by which time any opportunity to design out CGXP non-compliances would be long gone. Uncovered during IQ execution, the inevitable outcome would be a compromise in standards rather than the necessary alterations. For pure economy alone DQ makes sense, as potential shortcomings eradicated on the drawing board are an altogether cheaper solution.