Glossary · Engineering, integration and validation
User requirements specification (URS)
Also known as: URS, User requirements document
German: Benutzeranforderungsspezifikation (URS)
In automation and regulated industries, a user requirements specification (URS) is the document in which the customer or user states what a system must do and which conditions it must meet, from the user's point of view and independent of a technical solution. It is the starting point for specification, design and acceptance.
- Validation
- Process industry
In one sentence
A user requirements specification (URS) states what a system must do from the user's view, independent of the technical solution.
Example
The URS for a tablet press states the required output, product changeover time, cleaning requirements and the need for an electronic audit trail.
How it applies
- Engineering: Suppliers answer the URS with a Requirements specification or Functional specification; each user requirement should be traceable to how it is met and tested.
- Regulated industries: In GMP environments, the URS is the basis for qualification and validation, see EU GMP Annex 15 (qualification and validation) and Computerized system validation (CSV) and computer software assurance (CSA). Performance qualification checks the system against the URS.
- Acceptance: Acceptance criteria for Factory acceptance test (FAT) and Site acceptance test (SAT) trace back to the URS.
- Documentation: The URS should state documentation requirements, such as languages, formats, training material and electronic delivery. The documentation team uses it to plan deliverables and check them at acceptance.
URS vs. requirements specification
The URS, comparable to the German Lastenheft, is written by the user and describes needs. The Requirements specification (Pflichtenheft) is written by the supplier and describes the solution.