The User Requirements Specification (URS) defines what the user expects from the system from a business and compliance perspective, without describing technical design. It is the starting point for risk assessment, testing, and traceability in CSV.
Why URS is Critical:
URS drives:
- Risk Assessment
- FRS / DS
- IQ / OQ / PQ testing
- Traceability
If a requirement is not in URS, it should not be tested. (Reference: FDA — General Principles of Software Validation.)
What a Good URS Includes:
- Intended use & GxP impact
- Functional requirements
- User access & security
- Audit trail & data integrity (ALCOA+)
- Backup, restore, and data retention
All requirements must be clear and testable. (Reference: EU Annex 11)
What to Avoid:
URS should not include design or technical details—these belong to FRS / DS. Clear separation ensures proper validation and traceability.
Related Topics:
Reference: ISPE GAMP 5