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USER REQUIREMENT SPECIFICATION

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TABLE OF CONTENTS
Section Page
1. DOCUMENT CONTROL..........................................................................................................................................2
2. GENERAL DESCRIPTION.......................................................................................................................................3
3. SPECIFIC REQUIREMENTS...................................................................................................................................3
4. Definitions..................................................................................................................................................................6

1. DOCUMENT CONTROL

1.1 Revision History

Date Issued Revision Reason for Issue

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2. GENERAL DESCRIPTION

2.1 Overview
The objective of this URS is to inform the equipment supplier of the general and specific requirements that will form
the scope of supply. The supplier must provide a detailed specification that addresses the requirements of this URS.
The supplier should identify where their equipment differs from the clauses contained in this URS, specifically where
they are unable to meet these requirements. The specification may be provided in combination with a quotation or as a
separate document.

3. SPECIFIC REQUIREMENTS

3.1 Performance Parameters

Identify required performance parameters (specify acceptable limits)
For example:
 Speed
 Temperature
 Humidity
 Pressure
 Light level
 Noise level
 Size
 Shelf capacity
 Alarm functionality
3.2 Construction Standards
Construction standards are to be compliant with current GMP/GLP regulatory requirements.
Identify the following:
For example:
 Equipment should be CE marked
 Any product contact parts should be 304/316 stainless steel and traceable certificates of conformity supplied.
Where non-stainless product contact parts are used, these must be of a suitable material, e.g. PTFE, silicone,
with certificates of conformity provided.
 All working parts to be suitably enclosed and efficiently segregated from the product contact areas to prevent
ingress of process fluids which may affect the workings of the equipment and egress of oils, greases and other
potential contaminants.
 Designed to be easily and effectively cleaned with no product entrapment areas present.
 All connections to be of an appropriate design and construction, e.g. hygienic flanges for liquid product contact
and suitable fittings for dry services (compressed air, nitrogen, etc)
3.3 Engineering Standards
Engineering standards must comply with National and International Statutory Standards with respect to safety, noise,
guarding and interlocks, ingress protection, electrical/mechanical standards and levels of protection.

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 All wiring/pneumatics to be tagged at either end in accordance with electrical/pneumatic drawings. Similarly,
all components to be labelled in accordance with the drawings.
 Cabinets, panels, doors, etc must be suitably earthed and evidence provided that electrical signal, power,
continuity and earthing tests have been carried out. Ideally, this will be in the form of a test certificate
3.4 Utilities
Identify any requirement for the following:
For example:
 Mains electricity single phase 240v 50Hz.
 Mains electricity three phase 415v 50Hz.
 Compressed air @ 6 BarG.
 Mains water, chilled water,
 Gases (nitrogen, oxygen, C02)
 Compressed air
Any required utilities not shown above to be identified in the specification/quotation. Utility requirements must be
adequately specified to ensure that there is sufficient capacity.
3.5 General Documentation
Specify level of documentation to be supplied as standard.
For example:
 A detailed specification to be provided in response to this URS. This may be combined with the quotation or
provided separately.
 A general layout drawing.
 A CE declaration of conformity.
 All pre-installation tests, e.g. pressure tests, factory acceptance tests, and subsequent site commissioning tests
must be fully documented and provided prior to commencement of equipment validation.
 All instruments regarded as critical to the quality of the product, safety and/or operability of the equipment
must be calibrated and provided with suitable calibration certificates.
 An instrument list identifying the following critical parameters to be provided prior to FAT:
 Purpose of the instrument.
 Instrument supplier and model / type
 Identification of any safety devices.
 Instrument operating range and tolerance.
 A minimum of 2 hard copies of an Operating & Maintenance Manual are required. Electronic copies of
manuals and drawings are also preferred. Manuals must be written in plain English. Generic information will
not be accepted and this includes drawings and electrical diagrams. Typical information contained in the
manual:
 Operating instructions
 Cleaning procedures.
 Data sheets for all components and assemblies, including computer hardware.
 Instrument list with calibration certificates including instrument range and tolerance.

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 As-built drawings and electrical diagrams.

 Parts list with recommended spares identified.
 Fault finding guide.
 Commissioning data (to include any raw data).
 Service requirements.
3.6 Installation & Commissioning
Identify installation and initial commissioning requirements.
For example:
 Supplier to detail any special service or installation requirements.
 Supplier to provide suitable installation service.
 Commissioning report shall be provided prior to commencement of validation. This should demonstrate
satisfactory delivery, installation and testing.
3.7 Validation
Identify validation documentation requirements following risk assessment.
For example:
 Commissioning or Site Acceptance Testing (if performed) should be approved by the client prior to IQ/OQ.
 IQ to be provided that demonstrate the equipment has been installed according to the design intent
 OQ protocol for site qualification to be provided to demonstrate that the equipment operates as expected.
3.8 Computer Hardware & Software
This section only applies to equipment controlled by programmable software.
For example:
 For computerised systems test protocol must ensure that all operating functions specified in the Functional
Specification (FS) are tested effectively.
 Does the equipment support 21 CFR Part 11 requirements for electronic records
 Hardware/software back-ups should be available in case of systems failure
 Procedures should be provided for system recovery
3.9 Training
Identify on site training to be provided:
For example:
 Operators
 Maintenance engineers
 Training certificate is to be provided to each attendee for training records.
 Evidence that the trainer is suitably qualified for this purpose; this may be in the form of a CV or a company
statement.

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4. DEFINITIONS

AHU Air Handling Unit

CV Cleaning Validation
HFEA Human Fertilisation & Embryology Authority
HVAC Heating Ventilation and Air Conditioning
FS Functional Specification
cGMP current Good Manufacturing Practice
cGLP Good Laboratory Practice
HEPA High Efficiency Particulate Air
IQ Installation Qualification
MHRA Medicines & Healthcare products Regulatory Agency
O&M Operating and Maintenance (manual)
OQ Operational Qualification
PA Pascal’s
URS User Requirement Specification
SAT Site Acceptance Testing (Commissioning)
VMP Validation Master Plan
VPP Validation Project Plan
VSR Validation Summary Report

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