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 clean room design is dependent on a clear and concise User Requirement Specification (URS) to take through a successful Design Qualification (DQ).
User-Requirement-Specification-for-Automatic-External-Ampoules-Washing-Drying-Self-Adhesive-Labelling-Machine