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PLANREFERENCE OUTLINE
User Requirements Specification (URS)
URS capturing testable functional, operational, data integrity, and regulatory requirements with unique IDs and traceability — the anchor for design, risk assessment, and qualification. Maps to ASTM E2500 and GAMP 5.
REGULATIONS MAPPED
ASTM E2500ISPE GAMP 5
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A user requirements specification that states, testably, what a system or equipment must do — the anchor for design, risk assessment, and every downstream verification activity.
What's Inside
✓Functional and operational requirements
✓GxP, data integrity, and Part 11 requirements
✓Performance, capacity, and environmental needs
✓Regulatory and safety requirements
✓Traceability and acceptance references
How to Use It
1Capture requirements as discrete, testable statements
2Separate GxP-critical from business requirements
3Include data integrity and Part 11 needs explicitly
4Give each requirement a unique traceable ID
5Baseline under change control before design
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and System Overview
2Functional Requirements
3Operational and Performance Requirements
4GxP, Data Integrity, and Part 11 Requirements
5Regulatory and Safety Requirements
6Constraints and Interfaces
7Requirement IDs and Traceability
8Approval and Change Control
REGULATORY CONTEXT
ASTM E2500 and ISPE GAMP 5 make the URS the basis for risk assessment and verification. This template enforces testable, uniquely identified requirements that trace through qualification.