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.

Need support?

Looking for more information? Contact one of our cleanroom experts!


Related articles

You may also find these arictles useful:

Last updated:

Cleanroom Services

We don’t just design and build high quality critical environments; our expertise extends into a comprehensive array of cleanroom services.

Our GMP Team

See our latest projects!

Our case studies demonstrate successful collaborations with clients across the globe!