User Requirements Specification (URS)

Q: How is a URS different from a Functional or Design Spec?

The URS states what users need and why (business-owned). Functional/design specs state how the system will meet those needs (typically vendor/IT-owned).

Q: Who approves the URS?

Process owners and QA approve, with IT/validation sign-off via a governed approval workflow.

Q: Can we use agile and still have a URS?

Yes. Maintain a controlled URS baseline, iterate changes through MOC, and keep end-to-end traceability.

Q: How detailed should it be?

Detailed enough to be testable and inform configuration, but not prescriptive of design. If you cannot write an acceptance test from it, add detail; if it dictates UI layout, remove detail.

Q: What if a requirement is missed?

Raise a controlled change via MOC, update risk and traceability, and plan targeted testing before release.

Q: How do we keep the URS aligned with SOPs?

Link requirements to SOP references and trigger SOP/training updates through the traceability matrix and Training Matrix when requirements change.

User Requirements Specification (URS) – Functional Needs

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated October 2025 • Requirements, Validation & Procurement • Quality, IT, Manufacturing, Laboratory, Supply Chain

A User Requirements Specification (URS) is the business‑owned statement of what a system must do and how it must behave to be fit for intended use in a regulated operation. It is the anchor for selection, configuration, validation, and change control: vendors are chosen and solutions are built to satisfy the URS; test scripts and UAT are traced back to it; and future enhancements pass through its change process. In a CSV lifecycle aligned to GAMP 5, the URS precedes functional/design specifications and governs testing, electronic records expectations, and data integrity commitments.

“Write the URS as if an inspector will use it as a shopping list to verify your system and your records—because they will.”

TL;DR: A URS defines what users need—clear, testable, risk‑prioritized requirements covering functions, records, security, performance, integrations, reporting, and compliance (e.g., Part 11/Annex 11, Data Integrity, Record Retention). It is owned by the business under Document Control, approved via Approval Workflow, traced to tests in UAT, and maintained through MOC. Avoid design “how‑to” language—state verifiable outcomes.

1) What a URS Covers—and What It Does Not

Covers: business and regulatory needs expressed as requirements: what transactions must be possible (e.g., create/execute eBMR with enforced holds), what records must exist and be retrievable, who can perform which actions and under which controls, and how fast, accurate, and available the system must be. It includes reporting, labels, interfaces, data migration boundaries, auditability, and retention/disaster‑recovery needs. The URS is deliberately technology‑agnostic.

Does not cover: the solution design or implementation detail. Field names, database schemas, and screen layouts belong to the vendor’s functional/design specs. The URS should avoid prescribing mechanisms (“use table X” or “button on left”) and instead commit to outcomes (“record shows who/what/when/why with immutable audit trail and e‑signature binding”).

2) Regulatory & System Anchors

Regulators expect intended use to be defined and verified. A controlled URS, aligned to GAMP 5, drives proportionate CSV and test coverage. Requirements that touch electronic records and signatures must explicitly call out Part 11/Annex 11 behaviors (unique users, e‑signatures, audit trails, record protection). Data lifecycle expectations—ALCOA(+), metadata, archival, retrieval within timeframes—tie to Data Integrity and Record Retention. The document sits under Document Control with formal approvals and version history.

3) What a Good URS Contains

A strong URS opens with scope and boundaries (in scope apps, sites, products, and processes) and states intended use in plain language. It then frames functional requirements by process area—materials and warehouse control, production execution, quality records, laboratory workflows, labeling and traceability, and reporting/analytics. Each requirement is atomic, uniquely numbered, and testable. Nonfunctional requirements appear alongside: roles and permissions, data security and privacy, availability and performance expectations at peak loads, backup/restore and disaster recovery, localization and time zones, and usability constraints for shop‑floor devices. Integration requirements define what data must be exchanged with ERP, instruments, or partners and at what quality cadence. Finally, the URS lists acceptance criteria and references to governing policies and SOPs.

4) From Discovery to Approval—A Standard Path

Start by interviewing process owners and reviewing current SOPs, pain points, and audit findings. Map “day in the life” scenarios across modules—e.g., goods receipt to dock‑to‑stock, weigh and dispense with gravimetric controls, in‑process checks, and final disposition. Draft requirements, tag them with risk and priority, and circulate for cross‑functional review (QA, IT, Manufacturing, Lab, Supply Chain). Resolve conflicts, verify testability, and submit for formal approval. The approved URS becomes the baseline for vendor selection, configuration, and UAT; deviations or scope changes after approval must route through controlled MOC.

5) Writing Requirements That Inspectors Respect

Make each requirement measurable and unambiguous. Replace “user‑friendly” with objective criteria such as “the system displays out‑of‑range readings in real time and blocks progression until a supervisor e‑signs a deviation.” Avoid bundling (“and/or”) that hides separate needs; split them. Use consistent verbs (“shall …”) and specify actors (role names), inputs (data elements), outputs (records/reports/labels), and constraints (time limits, accuracy, devices). Tie critical requirements to risk justifications so testing depth is obvious and proportionate.

6) Nonfunctional Requirements Matter

Performance, availability, and resilience are not IT extras—they are business risks. Declare response times at line speeds, label print throughput, acceptable downtime windows, and recovery objectives. State password policies, session timeouts, and account lockouts within data integrity expectations. Define device constraints for scanners, scales, and HMIs, including behavior in low‑connectivity environments. Include localization (units, date formats), accessibility, and browser or OS support that mirrors where the system will run (e.g., cleanroom tablets vs. desktop PCs).

7) Data & Integration Requirements

State master‑data ownership (items, products/formulas, customers/suppliers), keys (lot/serial, GTIN, SSCC), and synchronization cadence. For lab and production, define instrument and device data capture and any TMV or calibration traceability required. For outbound traceability, specify EPCIS or EDI payloads and timing. The URS should also describe data migration boundaries—what historic data must be imported and to what level of detail—to avoid late surprises during cutover.

8) Compliance Content to Include Explicitly

Spell out Part 11/Annex 11 behaviors (unique user IDs, e‑sign prompts, signature meaning, record protection), audit trail expectations (who/what/when/why and reporting), and retention/archival rules (immutability, retrieval time). Where relevant, align with domain regulations (e.g., 21 CFR Part 211, ISO 13485, GDP). Confirm that reports, labels, and exported files meet content and format expectations, with barcode verification where used.

9) Acceptance Criteria & How URS Drives Testing

Every requirement should have acceptance criteria that a tester can execute without guesswork. Criteria reference specific outputs (e.g., an eBMR section ID, a label template version, a report name), role behavior, and pass/fail thresholds. During UAT, scenarios trace to these criteria, and defects trace back to requirement IDs—making risk coverage and release decisions transparent.

10) Traceability from URS to Evidence

Establish a traceability matrix that links each URS requirement to design/configuration objects, test scripts and results, associated risks and controls, and training/SOP updates. This single thread lets auditors pick any requirement and navigate to proof, and it prevents orphan tests or unvalidated features. When requirements change, the matrix shows exactly which evidence must be re‑worked.

11) Using the URS in Supplier Selection

Turn the URS into an RFP checklist. Ask vendors to respond requirement‑by‑requirement with “out‑of‑the‑box,” “configuration,” or “custom” indicators and to demonstrate high‑risk items live. Score proposals on how completely and natively they satisfy the URS and on their ability to preserve compliance (e.g., immutable audit trails) without custom code. This avoids buying features you cannot validate or support.

12) Managing Change—Keeping the URS Alive

After go‑live, new needs will emerge. Treat URS updates as controlled changes under MOC: assess impact, update risks, revise the traceability matrix, and plan targeted re‑testing. Align with policy and quality planning so requirements are refreshed at sensible intervals—not only during crises or audits.

13) Metrics That Demonstrate URS Quality

Traceability completeness: percentage of requirements linked to approved tests and passing evidence.
Risk coverage: share of high/medium risks with explicit, testable requirements and UAT scenarios.
Ambiguity rate: reviewer‑flagged items per 100 requirements (target < 2).
Change stability: requirement churn between draft and approval; high churn indicates unclear scope.
Defect leakage: UAT defects traced to missing/ambiguous requirements (drive toward zero).

Tracking these helps organizations improve requirement clarity and keep validation proportionate and efficient.

14) Common Pitfalls & How to Avoid Them

Jumping to design. Keep “how” language out of the URS; state observable outcomes.
Vague adjectives. Replace “intuitive/robust/fast” with measurable criteria and thresholds.
One giant requirement. Split into atomic, uniquely numbered statements that can pass or fail.
Ignoring nonfunctional needs. Performance, availability, and security belong in the URS, not in a separate IT memo.
No user ownership. The business must author and approve; IT facilitates, QA governs.
Uncontrolled edits. Use Document Control with version history and formal approval workflow.

15) What Belongs in the URS Record

Include scope and system identifiers; intended use; stakeholders and roles; requirement list with unique IDs, priorities, and risk tags; nonfunctional requirements; integration and data scope; acceptance criteria; references to policies, standards, and SOPs; and appendices for data dictionaries or process maps. Capture approval signatures, version history, and links to the traceability matrix, test plans, and training impacts in the same controlled record.

16) How This Fits with V5 by SG Systems Global

Authoring & Governance. The V5 platform provides governed URS templates in the QMS module. Authors create requirements under Document Control, apply risk tags, and route for e‑signature approval via Approval Workflow. Versioning is automatic and immutable, meeting audit‑trail expectations.

From URS to Tests. V5 turns each requirement into a testable object: it seeds UAT scenarios, links to validation plans in CSV, and maintains a live traceability matrix from requirement → configuration → test → result → training/SOP updates.

Risk‑Proportionate Coverage. Because requirements are risk‑tagged, V5 auto‑prioritizes test depth and evidence burden. High‑risk controls (e.g., e‑signature binding, inventory status changes in WMS, batch release in MES, lab approvals in LIMS) get stronger coverage by design.

Integration & Records. For interfaces (EDI, EPCIS, instruments, printers), V5 binds URS requirements to actual payload checks and device events. Evidence—screenshots, PDFs, label images, payload samples—is captured automatically and stored under Record Retention.

Change Control. When scope evolves, V5 raises a linked MOC, updates the URS version, and flags affected tests and SOPs for re‑work—keeping the whole chain inspection‑ready.

Bottom line: V5 makes the URS a living, governed artifact that drives selection, validation, and continuous improvement—not a PDF filed and forgotten.

17) FAQ

Q1. How is a URS different from a Functional or Design Spec?
The URS states what users need and why; functional/design specs state how the system will meet those needs. The URS is business‑owned; design is typically vendor/IT‑owned.

Q2. Who approves the URS?
Process owners and QA, with IT and validation sign‑off. Approvals follow governed workflow so accountability is clear.

Q3. Can we use agile and still have a URS?
Yes. Maintain a controlled URS baseline and iterate through change control. Break large requirements into epics/stories, but keep traceability and approvals intact.

Q4. How detailed should it be?
Detailed enough to be testable and to inform selection/configuration, but not a design manual. If a reader cannot write an acceptance test, it’s not detailed enough; if it prescribes button placement, it’s too detailed.

Q5. What if a requirement is missed?
Raise a change via MOC, update risks and the traceability matrix, and plan targeted testing before go‑live or as a controlled enhancement post‑go‑live.

Q6. How do we keep the URS aligned with SOPs?
Link requirements to SOP references and trigger SOP/training updates in the traceability matrix when requirements change. Use the Training Matrix to verify role readiness.