Purpose of a URS:
- Specify guiding regulations and industry and site standards the system must meet
- Specify deliverables
- Ensure each requirement has a unique number. This is for ease of traceability and referencing in other documents
- Evaluate the impact to quality in the URS itself. This will allow agreement up front for what requirements will need to be tested as part of qualification/validation, and which can be safety ignored.
- Each requirement should be specific and measureable so that it can be easily tested. While it’s tempting to include statements like “The XYZ system shall comply with applicable regulations” this statement really becomes meaningless because it is not specific enough, and is not testable.
Lots of examples from ISPE’s JETT consortium here.