Free download
URS Template Pack
A blank Word user requirements specification, formatted and ready to use: all thirteen sections, a document control block, revision history, a requirements table, a traceability matrix and an assumptions register. It is the same structure Pharma4i fills in for you.
What is inside
- 1. Purpose and scope
- 2. System overview
- 3. Definitions and abbreviations
- 4. Referenced documents
- 5. Regulatory and quality requirements
- 6. GxP impact assessment
- 7. Operational requirements
- 8. Performance requirements
- 9. Data, records and integrity
- 10. Interfaces and utilities
- 11. Materials of construction and cleanability
- 12. Safety, environment and ergonomics
- 13. Documentation, training and handover
Plus: requirements table, Appendix A traceability matrix, Appendix B assumptions register.
Get the Word file
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