User Requirement Specification (URS)
The URS is a definition of requirements to fulfil the demands of the process from the Users‘ point of view.
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 (DQ).
The DQ process will prove, line by line, how each requirement in the URS is met. This could be through design drawings, by technical data sheets and meeting regulatory rules and guidance.
All URS requirements must be met to allow unconditional approval of the DQ.
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