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User Requirement Specification Effective Date: <date>

User Requirement Specification: User Requirement

Specification

Document information, authorship and approvals

Author signs to confirm technical content
Prepared by: Job title: Signature: Date:

Subject matter expert reviewer signs to confirm technical content

Reviewed by: Job title: Signature: Date:

Quality representative signs to confirm document complies with quality management system
Authorised by: Job title: Signature: Date:

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 Document ID: <URS001>
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User Requirement Specification

Contents
1. Introduction 3
2. Objective 3
3. Scope 3
3.1. In-Scope 3
3.2. Out-of-Scope 3
4. Criticality & Risk Assessment 4
4.1. Criticality 4
4.2. Risk 4
4.3. Testing Requirements 4
5. Requirements 5
5.1. Compliance Requirements 5
5.2. Process & Operational Requirements 5
5.3. Constraints 6
5.4. Life-Cycle Requirements 6
6. Referenced Documents 9
7. Definitions 9

Notes
Fields marked [Company] or [Title], etc. can be updated within the document and should
change all other references to the field instantly.
All text provided is either instructional (red text) or example (black text) and should be
modified/deleted as appropriate.
Because URS can apply to very small and very large projects, it is difficult to provide
examples of requirements to cover all eventualities. The example text provided is for a
small HVAC system. It demonstrates how requirements should be written, but clearly
cannot cover requirements for all equipment types

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1. Introduction
This should be a very brief introduction how this URS has arisen and what it is for.
Company Name is procuring a _________ for their Company Address site. As part of this
procurement, a User Requirements Specification (URS) is required. This URS documents
the user and regulatory requirements for the User Requirement Specification. The URS
will be used as the basis of design and qualification for the User Requirement
Specification.
Note: in some cases, the URS is not the basis for design, and in some other cases,
‘selection’ may be a more appropriate term where there is no design phase involved.
It is also possible that a URS has been prepared retrospective to order. In these cases,
the introduction should make this clear and justify the position.

2. Objective
The objective of this URS is to define and document the requirements of the User
Requirement Specification at Company Address, including:
• design
• construction
• qualification
• operation
Appropriate definition and application of these requirements will result in an operational
facility in compliance with all user requirements as well as applicable regulatory
requirements.

3. Scope
What is in and out of scope may vary from one URS to another. These sections should be
edited accordingly.

3.1. In-Scope
The scope of this URS is limited to the User Requirement Specification at Company
Address. The plans and schedules provided in attachment 1 clearly identify the limit of
supply.
The URS details the following requirement types:
• compliance requirements
• process and operational requirements
• constraints
• life cycle requirements
The URS describes all the requirements deemed relevant to the items above for the User
Requirement Specification. Testing for each requirement is determined through criticality
and risk assessment as described in Section 4.

3.2. Out-of-Scope
This URS does not include:
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• statutory construction requirements, considered the responsibility of the builder and

their sub-contractors;
• architectural or engineering functional or detailed design, considered the responsibility
of the contracted designers;
• statutory requirements for occupational health, safety and environment, considered
the responsibility of the contracted designers.
• The URS is not applicable to general office and other areas not directly required for
the operation of the GMP facility

4. Criticality & Risk Assessment

4.1. Criticality
The User Requirement Specification has been assessed in accordance with SOP002 -
Criticality and Risk Assessment as follows:

Parameter Assessment Justification

Impact One of For example

Direct Product contact / controls critical parameters
Indirect Monitors critical parameters / required for compliance
Safety Personnel protection only
None Not required for GMP or safety compliance

4.2. Risk
This URS has been completed in accordance with SOP002 - Criticality and Risk
Assessment. Each listed requirement has been assessed for risk and assigned a Risk
Priority (High, Medium or Low). This risk priority should be used to make priorities for
design and/or testing requirements.
Each risk priority identifies the risk to product quality and/or other risks as deemed
relevant if the requirement is not implemented, or implemented incorrectly. The risk
priority is determined by analysis of:
• the severity of the risk event
• the probability of detection before occurrence
• and the likelihood of its occurrence without intervention.
This risk assessment has identified:
16 requirements of High risk priority
32 requirements of Medium risk priority
19 requirements of Low risk priority

4.3. Testing Requirements

Modify the level of testing required to suit the categorisations obtained.
Based on the risk and criticality categorisations above and in accordance with SOP002 -
Criticality and Risk Assessment for Validation and VMPXXX –Validation Master Plan, User

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User Requirement Specification

Requirement Specification requires Commissioning, followed by Design, Installation,

Operational and Performance Qualification as minimum testing requirements.
The level of testing conducted for each requirement shall be commensurate with the risk
priority identified in the requirements table in Section 5.

5. Requirements

Ref. Requirement Risk

5.1. Compliance Requirements

List all compliance requirements which must be met by the completed
project. GMP code(s) and guidances, ISO or national standards, OH&S
requirements, building codes, corporate policies, etc. may be listed here.
Redundancies (for example, building codes already referenced in tender
packages or design briefs) should be avoided, however.
U1. e.g. The User Requirement Specification shall comply with the M
requirements of Good Manufacturing Practice (GMP) for medicinal
products, as regulated by the Therapeutic Goods Administration (TGA) in
Australia (PIC/S Guide to Good Manufacturing Practice, PE009-8).

U2. e.g.The User Requirement Specification shall comply with the relevant M
requirements for manufacture of Sterile Medicinal Products, as regulated
by the TGA in Australia (PIC/S Guide to Good Manufacturing Practice,
PE009-8, Annex 1).

U3.

5.2. Process & Operational Requirements

List all process and operational requirements to be met by the completed
project. Consider capacities, performance specifications, layout, cleaning
requirements, waste handling, environmental requirements, finishes, storage
requirements, materials and personnel flows, etc.
General

e.g. The system shall supply a floor space of approximately 400m2,

partitioned as described in requirements U14 to U27. The system shall
U4. H
have no less than 2 air handling units (AHU) to supply approximately
8m3/s of air to the facility.

e.g.Temperature control shall be by cooling and reheat coils in each AHU,

U5. supplied by chilled and heating hot water systems dedicated to the HVAC M
system.

U6.

U7.

Finishes & Cleaning

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U8. e.g. The insulation inside the air handling units shall be non-shedding. L

e.g. The air handling units shall be provided with adequate access for L
U9.
cleaning.

5.3. Constraints
List all constraints that define the boundaries/limitations of the project, and
which are not inherent in the previously listed requirements. Consider space
constraints, site service availability, project time constraints, site standards
and policies, compatibility requirements with existing systems and equipment
e.g. Scheduled modification to building structure works requires
U10. L
completion and handover of the system prior to December 31, 2011.

e.g. The system shall be available 24 hours per day, 7 days per week.
U11. Routine maintenance events requiring system shut-down should be kept M
to a minimum.

5.4. Life-Cycle Requirements

Define the post-design requirements for accepting the equipment, such as
documentation, testing and warranty support.
Design Review

During the design phase, and as part of final design approval, design team meetings will be
conducted. The outcomes of these meetings will be recorded and compiled by Company
Name as the design review.

e.g. The design review shall demonstrate that the design meets all H
U12. relevant user, functional, design, regulatory and compliance
requirements.

Commissioning Requirements

At the completion of installation, the system shall be commissioned by the installer and/or
subcontractors to the installer, prior to handover to Company Name. The following are the
minimum requirements for commissioning.

e.g. All personnel performing commissioning testing shall supply evidence M

U13.
of accreditation by a relevant testing authority (e.g. NATA).

e.g. Tester shall supply documented evidence that the requirements of M

U14.
this URS have been met where appropriate.

Handover Documentation Requirements

e.g. The installer shall supply an operation and maintenance manual M

U15.
which includes as a minimum:

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• Identification of component parts and supplier literature for all

components which may require replacement
• Operating instructions for the system, and for individual
components where appropriate
• As-built system layout drawings
• As-built system specifications
• Contact details for suppliers and maintenance contractor(s)
• Preventative maintenance task list with recommended frequencies

QMS Documentation Requirements

e.g. Company Name shall ensure that the following SOPs have been H
created and/or updated for the system:
• operation
U16. • monitoring
• calibration
• maintenance
• cleaning

Qualification Requirements

At the completion of commissioning, the system shall be qualified by Company Name and/or
by consultants to Company Name, The following are the minimum requirements for
qualification.

e.g. The system shall require Installation, Operational and Performance M

U17.
Qualification in accordance with the assessment performed in Section 4.

U18. e.g. Qualifications shall be completed prior to routine use of the system. M

Life-cycle Testing

e.g. All controlling and monitoring sensors/displays for room pressure, M

temperature and humidity shall be added to the site calibration register
U19.
and calibrated in accordance with the frequency determined for each
item.

Maintenance

e.g. The system shall be installed with a warranty period of no less than L
U20.
12 months on all parts and labour.

e.g. The routine preventative maintenance schedule shall be included on M

U21.
the site maintenance register.

Training

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e.g Training shall be provided to all operations and maintenance M

U22. personnel and cover operation, monitoring, cleaning, safety, calibration
and maintenance. Training shall be documented and maintained.

Change Control

e.g. Changes made to the system after approval of the URS shall be M
U23.
subject to change control.

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6. Referenced Documents
The following documents may assist in the understanding of this specification

Document Number Document Title

7. Definitions
Term/abbreviation Definition

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Document Information
Revision History
Revision Modified by Change Description of Change
Control No.
01

Complete the above fields for each revision of this document. Ensure that there is
sufficient description of changes so that the change history of this document can be
followed. Additional columns can be added to include document/change tracking numbers
generated by your company’s systems if required (eg. change control).

Associated forms and procedures

Doc. No. Document Title

List all controlled procedural documents referenced in this document (for example,
policies, procedures, forms, lists, work/operator instructions

Associated records
Doc. No. Document Title

List all other referenced records in this document. For example, regulatory documents, in-
house controlled documents (such as batch record forms, reports, methods, protocols),
compliance standards etc.

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