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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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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 Specificati on.

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:

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

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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 Requirement Specification requires Commissioningr 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

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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.

UI.
e.g. The User Requirement Specification shall comply with the 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).

e.g.The User Requirement Specification shall comply with the relevant 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 400m 2, partitioned as described in
l.J4. requirements U14 to IJ27. The system shall 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 AHIJ, supplied by chilled and heating
1.15.
hot water systems dedicated to the HVAC system.

IJ6.

Finishes & Cleaning

IJ8. e.g. The insulation inside the air handling units shall be non-shedding.

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

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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 completion and handover of the system
I-no.
prior to December 31, 2011.

e.g. The system shall be available 24 hours per day, 7 days per week. Routine maintenance events
Ull.
requiring system shut-down should be kept 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 relevant user, functional,
U12.
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 of accreditation by a relevant
U13.
testing authority (e.g. NATA).

e.g. Tester shall supply documented evidence that the requirements of this URS have been met where
appropriate.

Handover Documentation Requirements

U15. e.g. The installer shall supply an operation and maintenance manual 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 created and/or updated for the
U16.
system:

operation 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

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.

Life-cycle Testing

e.g. All controlling and monitoring sensors/displays for room pressure, temperature and humidity shall
U19. be added to the site calibration register 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 12 months on all parts and
IJ20.
labour.

U21. e.g. The routine preventative maintenance schedule shall be included on the site maintenance register.

Training

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e.g Training shall be provided to all operations and maintenance personnel and cover operation,
IJ22. monitoring, cleaning, safety, calibration and maintenance. Training shall be documented and
maintained.

Change Control

IJ23. e.g. Changes made to the system after approval of the URS shall be subject to change control.

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User Requirement Specification

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

Document Number Document Title

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 tiere 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 (ego change control).

Associated forms and procedures

Doc. No. Docu ment Title

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

Associated records
Doc. No. Docu ment Title

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

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