The blank URS template
This is the exact document structure the Pharma4i URS module produces. It suits equipment and computerised systems purchased or built under a GMP quality system, including systems assessed under GAMP 5 categories 3, 4 and 5. No account is needed to read or download it.
Requirement categories
Every requirement in the template belongs to one category. An empty category is stated as empty in the export rather than left out, so a reviewer can see that it was considered.
- Operational
- Functional
- Data / records
- Data integrity (ALCOA+)
- Security and access control
- Audit trail
- Interfaces
- Environmental / utilities
- Materials of construction
- Cleaning and maintenance
- Safety
- Documentation and handover
- Regulatory compliance
- Qualification support
USER REQUIREMENTS SPECIFICATION (URS) Document number: URS-XXXX-001 Revision: 0.1 Status: Draft System name: Equipment type: Site: Author: Date: 1. PURPOSE AND SCOPE 1.1 Purpose 1.2 Scope of the system 1.3 Out of scope 2. SYSTEM OVERVIEW 2.1 System description 2.2 Process context 2.3 Interfaces to other systems 2.4 GxP impact assessment (GxP / non-GxP, rationale) 3. DEFINITIONS AND ABBREVIATIONS 4. REFERENCED DOCUMENTS (site procedures, standards, regulatory texts) 5. REQUIREMENTS Each requirement carries a unique identifier, a category, a priority (Mandatory / Desirable) and is written to be verifiable. ID CATEGORY REQUIREMENT PRIORITY URS-001 Operational URS-002 Functional URS-003 Data / records URS-004 Data integrity (ALCOA+) URS-005 Security and access control URS-006 Audit trail URS-007 Interfaces URS-008 Environmental / utilities URS-009 Materials of construction URS-010 Cleaning and maintenance URS-011 Safety URS-012 Documentation and handover URS-013 Regulatory compliance URS-014 Qualification support 6. ASSUMPTIONS Assumptions carried while authoring, to be confirmed before issue. A-01 A-02 7. ACCEPTANCE AND TRACEABILITY 7.1 Verification method per requirement (IQ / OQ / PQ / design review) 7.2 Traceability approach 8. APPROVALS Author Name / Role / Signature / Date Reviewer Name / Role / Signature / Date Quality approval Name / Role / Signature / Date 9. REVISION HISTORY Revision Date Description of change Author 0.1 First draft
Fill it in with the generator
The URS generator walks you through project setup and a structured questionnaire, or reads a vendor specification and drafts candidate requirements from it. Unconfirmed values are recorded as open assumptions, not silently asserted, and the export matches this template with an approvals block ready for signature.