User Requirements Template RAJA

USER REQUIREMENTS Page 1 of 25
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RAJA SPECIFICATION
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BLANK TEMPLATE June 2018
USER REQUIREMENTS TEMPLATE

FOR A SYSTEM
(INSERT YOUR SYSTEM DESCRIPTION HERE)
JOINT EQUIPMENT TRANSITION TEAM

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REVISION HISTORY
Rev. Date Developed By: Revision Summary

0 04/01/2001 JETT Initial Release
1 10/17/2002 MTFilary 1st Revision of the Blank Template based on input
from users via JETT monthly meetings, email, and the
JETT website.
2 09/15/2003 MRivera Format review based on input from users via JETT
monthly meetings.
3 06/30/2004 MTFilary Revised the Blank Template based on input from users
via JETT monthly meetings, email, and the JETT
website.
The revision history section should be utilized during development to provide

information that will allow the reviewer/approver to understand what part/parts of the
document is/are being revised. For an initial release, provide a note that the document
is being routed for initial review/approval. This will ensure reviewers/approvers
evaluate the entire document. In the revision summary include the revision number
of the Blank Template used to create any equipment specific templates.
(Reminder of Page Intentionally Left Blank)

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TABLE OF CONTENTS
1.0 INTRODUCTION (SCOPE)............................................................................. 4
2.0 OVERVIEW ....................................................................................................... 5
3.0 OPERATIONAL REQUIREMENTS .............................................................. 6
3.1 CAPACITY ........................................................................................................ 6
3.2 PROCESS REQUIREMENTS ............................................................................... 6
3.3 PROCESS CONTROL ......................................................................................... 6
3.4 FUNCTIONS ...................................................................................................... 6
3.5 DATA AND SECURITY ....................................................................................... 9
3.6 ENVIRONMENT............................................................................................... 10
4.0 CONSTRAINTS............................................................................................... 13
4.1 MILESTONES AND TIMELINES ....................................................................... 13
4.2 EQUIPMENT CONSTRAINTS ........................................................................... 14
4.3 COMPATIBILITY AND SUPPORT ..................................................................... 14
4.4 AVAILABILITY ............................................................................................... 16
4.5 PROCEDURAL CONSTRAINTS ........................................................................ 16
4.6 MAINTENANCE .............................................................................................. 17
5.0 LIFE-CYCLE ................................................................................................... 19
5.1 DEVELOPMENT .............................................................................................. 19
5.2 TESTING ......................................................................................................... 19
5.3 DELIVERY ...................................................................................................... 19
5.4 SUPPORT ........................................................................................................ 21
6.0 GLOSSARY...................................................................................................... 22
7.0 REFERENCES ................................................................................................. 23
8.0 APPROVAL ..................................................................................................... 24
9.0 ATTACHMENTS ............................................................................................ 25

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Project No.:
Insert the unique project number associated with this particular URS.
Document No.:
Insert the Document Identification Number and Revision.
Document Description:
Insert description of document, e.g. PURE STEAM GENERATOR, JETT Example
User Requirements Specification.
1.0 INTRODUCTION (SCOPE)

Note: Insert your own description and introduction. You may wish to include
your own requirements and specifics to provide the inexperienced reader,
contractors, and suppliers an adequate explanation to understand the scope of
the equipment.
Describe who produced the document, under what authority, and for what
purpose.
Describe the contractual status of the document. Include or reference as an
attachment the “legal” paragraph that communicates purchasing terms and
conditions in this section.
Describe the relationship of this document to other documents. This is
important for equipment that is part of an integrated process or line and will
help the Supplier to understand and ask questions that may otherwise be
overlooked.
Refer to the Equipment Validation Plan that outlines the Supplier’s
responsibilities is attached.
Remove any options that are not applicable for this project, if other uses will
apply list each separately.
This is to be utilized as a guide for the user to answer the majority of questions
involved in specifying the “what” for the equipment. Addendums may be used
to round out the requirements.

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2.0 OVERVIEW
This document encompasses the normal range of equipment operations. This
section should be expanded to provide a high level description of the system
explaining why it is required and what is required of it. Include the background,
key objectives and benefits, main functions and interfaces, applicable GxP
requirements, and other applicable regulations. Obviously, technology
improvements and new applications may require deviation from this template.
The User should consider including information on the following:

2.1 Use: Describe what applications the equipment/system will be used to
support. Include a brief explanation of the general functions.
For example (for a Wide Range Filler):
2.1.1 The wide range filler line shall process pharmaceutical vials
under sanitary conditions with the following functions: vial
filling, put stoppers to vials, oxygen reduction, sample check
weighing, and vial eject.
For equipment dealing with solid dosage pharmaceutical products
directly:
2.1.1 The products being developed on the specified equipment are of:
2.1.1.1 Low active (vitamins, supplements)
2.1.1.2 Medium active (e.g. Aspirin)
2.1.1.3 Highly active (e.g. Morphine)
2.1.1.4 Exclusive (e.g. Penicillin)
2.2 Capacity: Provide a brief description of the equipment/system capacity
requirements.
For example (for a Wide Range Filler):
2.2.1 The equipment shall be capable of producing XYZ product
continuously, over an 8-hour shift.

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3.0 OPERATIONAL REQUIREMENTS

This Section shall state the operational requirements: system functions, data and
interfaces. It shall also define the environment in which the system must
operate. Critical requirements shall be specifically identified as such. Include
process descriptions and flowcharts as appropriate.
3.1 Capacity
3.1.1 Range of products
3.1.2 Commodities to be used (i.e. vials, bottles, tablets, etc.)
3.1.3 Processed Materials to be used or involved
3.1.4 Production rates
3.2 Process Requirements

3.2.1 Quality of products and concentrations
3.2.2 Product limitations (i.e. temperature, humidity, pH, etc.)
3.3 Process Control

3.3.1 Measurement Range
3.3.2 Setpoint Range
3.3.3 Parameter Control Tolerance
Note: At a minimum, list the critical, process parameters.
Consider documenting how each of the parameter requirements
was determined.
3.4 Functions
3.4.1 Operation
Enter your specific operational requirements here.
3.4.1.1 Cycles expected the system will operate at are…
3.4.1.2 Recipes the system will contain are…
3.4.1.3 Operator interaction with the system will include…
The following is an example:
3.4.1.1 The system shall operate with a minimum of operator
involvement. Operation shall be safe from an operator
and environmental standpoint.
3.4.1.2 The system shall be operated locally at the equipment
itself.
Control system requirements:

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3.4.1.4 Manual only

3.4.1.5 Manual/automatic
3.4.2 Power failure/Recovery
3.4.2.1 Power Failure: Insert your specific power
failure/recovery scheme here.
For example:
In the event of a power failure, the system shall protect
in the following priority:
3.4.2.1.1 Personnel
3.4.2.1.2 Equipment
3.4.2.1.3 Product
3.4.2.2 Recovery Methods: Insert your specific recovery scheme
here.
For example:
3.4.2.2.1 Manually re-start based on operator inputs

(Operator initiates power recovery sequence).
3.4.2.2.2 Re-start based on last state before loss of

power. (System runs through power recovery
sequence when operator start signal is given)
3.4.2.2.3 If there is an automatic batch reporting

system, the information shall be retained in
the event of a power failure (A UPS is
required for automatic batch reporting
systems for data retention).
3.4.3 “Emergency Stop”
Insert your specific “Emergency Stop” (E-Stop) strategy and
communication scheme here.
For example:
3.4.5.1 The system shall have an E-Stop mechanism designed to
stop all physical movement of the equipment immediately.
The E-Stop mechanism(s) shall be located in easily
accessible areas around the equipment as required by
national and local safety standards.
3.4.4 Alarms and Warnings
3.4.4.1 “Critical alarms” - Insert your specific “Critical

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Alarm” action scheme here.

For example:
3.4.4.1.1 Critical Alarms shall take action via

interlock(s) and/or operator procedural
response to shut the equipment down and
notify the operator of the condition(s).
The operator shall be required to
acknowledge the alarm before the alarm
can be reset and the system restarted.
Once the alarm is reset, the operator may
restart the system.
3.4.4.2 “Informational Messages” shall notify the operator and
take no further action.
Note: For a customized equipment application, include
an alarm table, like the example that follows.
For example:
3.4.4.2.1 The Equipment shall have the following

critical alarms and warnings:
Stackpole Light Response
Critical Informational
Alarm or Informational Message Illumination Operator
Alarm Message Interlock(s)
(color/flashing) Procedural
Emergency Stop X X
Control Platform Communication
X X
Watchdog
Control Power Fault X X
Main Air Fault X X
XXXX X
YYYY X
ZZZZ X
Motor Faults X X
CONTROL PLATFORM Battery Low
X X
Warning
The list of critical alarms in the table is not intended to be a

comprehensive list of all alarms for the system. A complete alarm
list will be developed and included in the Functional Specification
document.

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For a standard equipment type application, request the supplier to

submit the complete alarm list and differentiate between critical
and non-critical alarms.
Note: Consider documenting how “critical and informational
message” criterions were determined.
3.5 Data and Security

Controls provided with Data Collection systems intended for use in the
manufacture of pharmaceutical products shall be required to meet 21
CFR Part 11 compliance.
3.5.1 User Interfaces
This section should address the following issues:
3.5.1.1 User interface access levels
3.5.1.2 Frequency of data point collection
3.5.1.3 Hardcopy/electronic data collection requirements
3.5.1.4 Compliance with 21CFR Part 11 (for Europe - EREC
Guidelines)
3.5.1.5 Data retention time on the system
3.5.1.6 Data storage media
Access to all Input/Output values and system status bits
shall be provided through a data-communication link.
Security for data and operator access is provided by
(User ID/Password, Card Reader, Biometric
(Fingerprint, eye scan, voice recognition, etc.).
3.5.2 User Interface with Supervisors and Operators
Insert your interface scheme here.
For example:
3.5.2.1 The CONTROL PLATFORM system shall include
interfaces with the Operator and Supervisor that ensures
easy, safe, and reliable operation.
3.5.2.2 An operator-interface panel shall be provided and mounted
near the equipment or on the equipment. This panel shall
provide the necessary switches, indicators, and devices to
operate the equipment.
3.5.3 Language requirements
Specify language that information will be displayed in (i.e.
English, Spanish, German, Bilingual, etc.)
3.5.3.1 Displayed Requirements:

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State the system of measurement that will be used

(English or Metric (S.I.)).
Parameter Format Unit(s) of measurement
XXXXXXX (###.#) units units
YYYYYYY (##)% %
3.5.4 Interface with Other Equipment

The control system shall include the interfaces necessary to
facilitate operation and configuration. For example:
3.5.4.1 An RS-232 communications port shall be provided.
3.5.4.2 A Modem communications port shall be provided.
3.5.4.3 A high-speed configuration/monitoring connection shall
be provided.
3.5.5 Security Levels
List the total number of different access levels that will be
required. Provide a general description of the access rights for
each level (screen navigation, operational control, control loop
variable manipulation, alarm setpoint manipulation, etc.).
3.5.6 Data Collection
Consider any archiving and reporting requirements here.
3.5.6.1 None
3.5.6.2 Recorder
3.5.6.3 Process Printout
3.5.6.4 Electronic process printout, Historical Trending
3.5.6.5 Electronic process printout, Historical Trending and
interface to company network
The following shall be recorded:
3.5.6.6 XXXXX
3.5.6.7 YYYYY
3.5.6.8 ZZZZZ
3.6 Environment
Provide details of the physical environment in which the
[equipment/system] will be operated.
3.6.1 Layout
For example:
3.6.1.1 Allocated floor space for the equipment is _____ inches

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by ________ inches with at least a _______inch

corridor around the periphery for the equipment.
3.6.1.2 Vertical clearance is _________ inches.
3.6.1.3 Floor Loading is pounds/ft2
3.6.1.4 See attached drawing #________________________ (if
applicable).
Layout is specific to the size equipment being used and system
requirements of the equipment.
3.6.2 Physical Conditions
3.6.2.1 Room Explosion Classification
List the critical explosion requirements for the room.
3.6.2.1.1 Room will be non-hazardous
3.6.2.1.2 Room will be Class I Div II (Zone 2)

(explosive atmosphere present at known
times)
3.6.2.1.3 Room will be Class I Div I (Zone 1)

(explosive atmosphere present at all times)
3.6.2.2 Environmental Classification
List the critical air quality requirements for the
environment.
3.6.2.2.1 ISO Class 5, 7, or 8 (ISO 14644-1 and ISO

14644-2)
3.6.2.2.2 Class A, B, C, or D (The Rules Governing

Medicinal Products in the European Union
– Annex 1)
3.6.2.2.3 Directional airflow
3.6.2.2.4 Airflow velocity
3.6.2.2.5 Number of air changes
3.6.2.2.6 Particle Ingress

3.6.2.3 Biohazard Level
List the critical biohazard level requirements for the
environment.
3.6.2.3.1 BL-1
3.6.2.3.2 BL-2

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3.6.2.4 Rating of enclosures

List the rating requirements for enclosures in the
environment.
3.6.2.4.1 NEMA 1 (Open)
3.6.2.4.2 NEMA 12 (Oil tight)
3.6.2.4.3 NEMA 4 (Wash down)
3.6.2.4.4 NEMA 4X (Wash down and non-
Corrosive)
3.6.3 Cleaning Requirements
3.6.3.1 Hand-Wash
3.6.3.2 Auto-Wash
3.6.3.3 Steam Clean
3.6.4 Sterilization Requirements
Describe the type of sterilization that will be performed on or
within the [equipment/system] and the duration the
[equipment/system] will be exposed.
3.6.5 Intended Operating Environment:
Describe the type of operating environment that the
[equipment/system] will be exposed to following installation.
For example:
3.6.5.1 The [equipment/system] shall be mounted in a GMP
environment with a temperature range of 15 to 25 °C,
non-condensing humidity.
3.6.5.2 Vibration levels in operating environment are
<Negligible, Slight, or Severe>
3.6.5.3 The Seismic Zone in the operating environment is <Zone
1, Zone 2, Zone 3, Zone 4, or Zone 4A>.

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4.0 CONSTRAINTS
4.1 Milestones and Timelines
Based on the model outlined below, establish the project milestones with a
timeline:
JETT EQUIPMENT ACQUISITION MODEL

USER/(CONSULTANT if applicable) SUPPLIER
Master Validation Plan User Audit
Equipment Validation Plan/ Engineering Feasibility Study

Risk Assessment P.O. and Results
• Explanation to Supplier RFQ
User Requirements Proposal
Specification Proposal • Quality & Validation Plan • Project Plan
(Living Document)
P.O. Functional
Proposal Analysis Specification
(traceable to URS)
Approval Detailed Design

Review Functional Specification Documentation
(traceable to Functional Specification)
Approval System Acceptance Test

Review Detailed Design
Specifications (IQ/OQ)
Review System • Hardware • Software

Acceptance Test Specifications Approval System Acceptance
Testing and Results
User Witness Optional
Integrate with Validation
Documentation as appropriate Maintenance & Support
Documentation

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4.2 Equipment Constraints

Describe the operating constraints that the [equipment/system] will be
required to meet.
For example:
4.2.1 Environmental Conditions
The [equipment/system] is to be used at the following
environmental conditions:
4.2.1.1 Altitude ________ ft above sea level
4.2.2 HVAC Equipment Constraints
4.2.2.1 Process air enters in from…
Indoor Temperature: C
4.2.2.2 Outdoor Temperature:
Minimum: C
Maximum: C
4.2.2.3 Climatic conditions:
Winter dry bulb C
Winter wet bulb C
Summer dry bulb C
Summer wet bulb C
4.2.3 Equipment Generated Vibration
The maximum allowable equipment vibration generated during
operation is <value>.
4.3 Compatibility and Support

Include any requirements for compatibility with other User systems. In
the examples provided below, fill in blanks with the appropriate
information. Delete areas that are not applicable to this application.
4.3.1 CONTROL PLATFORM Controllers
4.3.1.1 The Supplier shall utilize Control Platform
Controllers that shall include a communications port.
4.3.1.2 The Supplier shall provide documentation that the
program (embedded software) was developed and coded
utilizing program development and
documentation software.
4.3.1.3 The supplier shall indicate the use of custom or
“bespoke” code within the equipment, and shall supply

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licensing of the custom code for the life of the

equipment.
4.3.1.4 An escrow agreement shall be required in the event the
supplier cannot support the supplied custom software
any longer. In such instances, the source code and all
information regarding the source code shall be given to
the user in a timely fashion to prevent downtime of the
equipment.
4.3.2 Preferred Vendor List
4.3.2.1 If necessary attach any critical preferred vendors.
Refrain from driving the supplier into customizing his
equipment package.
4.3.2.2 If the vendor wishes to deviate from the Preferred
Instrumentation List, a listing of the proposed
components and instrumentation sub-vendors indicating
type and model numbers shall be submitted with the
quotation, along with an explanation of why the
deviation is recommended.
4.3.3 Utilities
4.3.3.1 The utilities and space involved needs to be discussed
prior to purchasing the equipment. Obviously, the actual
equipment size is but a small part of the entire scope of
work necessary to implement a larger system. The unit
and its support equipment must be able to be installed in
current building facilities.
4.3.3.2 The User shall ensure that the following utilities are
available and that the utility supply lines and piping are
terminated with fittings or connections, which are
compatible with those described on the Customer
Connection Drawings.
4.3.3.3 The Supplier shall specify utility data, which is marked
with a triangle. Utility data, which are not specified or
marked with a triangle, shall be brought to the attention
of the User. These data shall be specified (by the User
or the Supplier) and shall be approved by both the User
and the Supplier before system design begins.
Base Utilities Worksheet
4.3.3.4 Related Discharges
4.3.3.4.1 Volume
4.3.3.4.2 pH

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4.3.3.4.3 Temperature
4.3.3.4.4 Materials
4.3.3.5 Electricity
4.3.3.5.1 ______ VAC ____ Hertz
4.3.3.5.2 Phases
4.3.3.5.3 Amperage
4.3.3.5.4 Uninterruptible Power Supply (Define

Use)
4.3.3.6 Control Air
4.3.3.6.1 Pressure
For example:
_______ PSIG (must be clean, dry ISA
instrument quality air, capacity to be
determined by size of equipment).
Recommend at least 90 PSIG constant air
pressure for all equipments, unless
specified.
4.3.3.7 Other Utility Requirements
Provide details regarding any other utility systems that
are required to support operation of the
equipment/system.
4.4 Availability
4.4.1 The [equipment/system] is intended to be operated [Continuously,
Regularly, __ hours per day, __ hours per week].
4.4.2 Operation of the [equipment/system] shall be suspended, and the
system shall be available for preventative maintenance or routine
service [__ hours per week, __ continuous hours per week, __ days
per month, __ weeks per year].
4.5 Procedural Constraints

4.5.1 Product Contact Materials
Describe any local procedural requirements such as local
standards, which must be adhered to if applicable.
4.5.1.1 All piping welds and product contact welds shall meet
ASME and 3A specification requirements.
4.5.1.2 Product contact metal to be (316L Stainless Steel, 316

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Stainless Steel, 304 Stainless Steel, etc.)

4.5.1.3 List critical requirements for surface finish, roughness,
etc.
4.5.1.4 Other standards are attached.
The Supplier shall adhere to the indicated sections only.
4.5.2 Product in Contact with Materials
All product contact parts should be considered.
4.5.2.1 The [equipment/system] will be used for (aqueous
solutions, low LEL (lower explosion limit) solvents,
high LEL solvents, etc.).
4.5.3 Noise Level Constraints
Insert your own noise level constraint requirements here.
For example:
The noise level generated during operation of the
[equipment/system] will not exceed 85 dB from 3 feet away.
4.5.4 EMI / RFI levels are:
Insert your own electrical and radio noise immunity requirements
here.
For example:
The [equipment/system] [will/will not] be used in an area where
two-way radio communication devices are in operation. The
[equipment/system] shall meet CE requirements for electrical
noise immunity and emissions.
4.5.5 Containment
4.5.5.1 Explosion Protection
This section is only valid if the product being used is
highly reactive. Insert containment guidelines here (i.e.
Bar Construction with isolation and suppression, 10 Bar
construction with isolation only, Closed-Loop Nitrogen
System, etc.).
4.5.6 Labeling
All equipment and control wiring shall be labeled and identified.
4.6 Maintenance
Describe the expected hardware and software maintenance support
including: ease of maintenance, expansion capability (software only),
likely enhancements (software only), expected lifetime and long-term
support.

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4.6.1.1 System shall be maintained on a schedule as indicated by

the supplier.
4.6.1.2 Supplier is to provide (at minimum) the following
maintenance instructions:
4.6.1.3 All sub-systems provided (Maintenance and operation
manuals of vendor equipment)
4.6.1.4 A comprehensive lubrication list and recommended
lubrication schedule
4.6.1.5 A comprehensive recommended maintenance (regular
recommended inspection intervals, wear points,
recommended spare parts list)
4.6.1.6 Supplier shall supply ______ Copies of Operation,
Installation, Maintenance and de-commissioning manuals
4.6.1.7 Accessibility for operation and maintenance personnel.

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5.0 LIFE-CYCLE
5.1 Development
If S88 is to be applied to the equipment being acquired, it should be
referenced in this section of the document.
5.1.1 The Supplier shall provide a Quality and Project Plan as part of
their proposal. The Supplier shall have a quality system in place.
Internal quality procedures shall be available for the User’s review.
5.1.2 The Supplier shall provide a Project Manager for the project to
provide a single communication point with the User.
5.1.3 The project shall utilize the GAMP methodology when developing
the system and documentation.
5.2 Testing
Describe the Supplier testing requirements. Reference the Validation Test
Plan, Factory Acceptance Test, special tests, etc. This section should also
include required amount of demonstrated run time, any special materials
necessary to complete testing, integration testing, etc.
5.2.1 In order to verify system performance, the User shall witness the
execution of the Factory Acceptance Test procedures. The
Supplier shall notify the User _______ weeks in advance of the
start of this test.
5.2.2 The Factory Acceptance Test Specification shall be submitted to
the User for review and approval prior to execution. A minimum
of _______ weeks shall be allowed for the User to review and to
comment and/or approve the Factory Acceptance Test
Specification.
5.2.3 The User shall notify the Supplier of the length of runs required,
special materials required, and any other unique test requirements
_______ weeks in advance of the start of testing.
Refer to the Equipment Validation Plan for applicable procedures.
5.3 Delivery
The [equipment/system], with all options, equipment, and the
documentation listed below, shall be delivered to the User’s receiving
dock.
5.3.1 Documentation
5.3.1.1 Installation, operation, and maintenance instruction
documentation for the system shall be developed to a
level that is comprehensible to a high school graduate.
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5.3.1.2 The Supplier shall use the formats described in the

GAMP Supplier Guide, Current Version, to produce the
documentation. The Supplier shall provide the
documentation for preliminary review. The Supplier
shall provide documentation reflecting “as-built”
condition with final delivery.
5.3.1.3 All final documents shall be shipped with transmittals
that identify them as contractually required documents.
All final documents and drawings shall reflect “as-built”
condition.
5.3.1.4 All documents shall in the language of the destination
country and supplied with hard copies and electronic
versions supplied in the format identified for each
document:
• Project Plan Microsoft Word XX (*.doc)
• User Requirements Specification Microsoft Word XX (*.doc)
• Functional Specification/Requirement Microsoft Word XX (*.doc)
• Design Specifications Microsoft Word XX (*.doc)
• Controls Test Microsoft Word XX (*.doc)
• Hardware Installation Test Microsoft Word XX (*.doc)
• Operational Test Microsoft Word XX (*.doc)
• Factory Acceptance Test Microsoft Word XX (*.doc)
• Operator, Maintenance and Service Manuals Microsoft Word XX (*.doc)
• Process and Instrumentation Diagram (P&ID) AutoCAD version XX.X (*.dxf)
• Instrument Listing Microsoft Word XX (*.doc) or Excel XX (*.xls)
• Control Schematics AutoCAD version XX.X (*.dxf)
• Control Panel Assembly Drawings AutoCAD version XX.X (*.dxf)
• Equipment Assembly Drawings AutoCAD version XX.X (*.dxf)
• Bill of Materials Microsoft Word XX (*.doc) or Excel XX (*.xls)
• Spare Parts List Microsoft Word XX (*.doc) or Excel XX (*.xls)
• Component Cut Sheets Microsoft Word XX (*.doc) or Excel XX (*.xls)
• CONTROL PLATFORM Program Printout and Disk File XXX Program Development format
• OIP Configuration Printout and Disk File XXX Program Development format

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5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
5.4.1 Start-up Support (list available options)
5.4.1.1 Training (list training options available)
5.4.2 Post Start-up Support (list post-startup support available)
5.4.2.1 Technical Support
5.4.2.1.1 Telephone (Voice or Modem)
5.4.2.1.2 Replacement Parts Availability List

(Normal lead times shall be listed)
5.4.2.2 User Site Support
5.4.2.2.1 Preventative Maintenance (list

maintenance contracts available)
5.4.2.2.2 System Improvements (supplier shall

notify user of any improvements available
on a regular basis)

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6.0 GLOSSARY
If necessary, attach a glossary, which includes definitions of terms that may be
unfamiliar to the Supplier or terminology that may have meanings specific to
entries on this User Requirements Check sheet.
For example (example list is not intended to be complete):
Acronym Definition
C Degrees Celsius
BL Biohazard Level
CFR Code of Federal Regulations
dB Decibels
EMI Electro-Magnetic Interference
ft Feet
GUI Graphic User Interface
HMI Human – Machine Interface
HVAC Heating, Ventilation, and Air Conditioning
ISO International Organization for Standardization
JETT Joint Equipment Transition Team
LEL Lower Explosion Limit
OIP Operator Interface Panel
RFI Radio Frequency Interference
URS User Requirement Specification

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TEMPLATE Rev.3
7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details, such as:
7.1 Equipment Validation Plan
7.2 Current revision of GAMP Guidelines
7.3 Vendor Piping Certification (if applicable)
7.4 Customer Connection Diagram
7.5 Approved Instrumentation List
7.6 Process Flow Diagram
7.7 21 CFR Part 11
7.8 National Electric Code
7.9 S88

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8.0 APPROVAL
Insert your company’s standard approval page at the appropriate position in
the document or utilize the sample approvals listed below. The approval
process/requirements should be outlined in the Equipment Validation Plan.
This document has been reviewed by the User Project Manager and approved for use by the
Supplier.
Printed/Typed Name Signature Date
This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.
This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.
Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.

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9.0 ATTACHMENTS

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USER REQUIREMENTS Page 1 of 25

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USER REQUIREMENTS TEMPLATE

JOINT EQUIPMENT TRANSITION TEAM

Rev. Date Developed By: Revision Summary

The revision history section should be utilized during development to provide

(Reminder of Page Intentionally Left Blank)

JOINT EQUIPMENT TRANSITION TEAM

JOINT EQUIPMENT TRANSITION TEAM

1.0 INTRODUCTION (SCOPE)

JOINT EQUIPMENT TRANSITION TEAM

The User should consider including information on the following:

JOINT EQUIPMENT TRANSITION TEAM

3.0 OPERATIONAL REQUIREMENTS

3.2 Process Requirements

3.3 Process Control

JOINT EQUIPMENT TRANSITION TEAM

3.4.1.4 Manual only

3.4.2.2.1 Manually re-start based on operator inputs

3.4.2.2.2 Re-start based on last state before loss of

3.4.2.2.3 If there is an automatic batch reporting

JOINT EQUIPMENT TRANSITION TEAM

Alarm” action scheme here.

3.4.4.1.1 Critical Alarms shall take action via

3.4.4.2.1 The Equipment shall have the following

The list of critical alarms in the table is not intended to be a

JOINT EQUIPMENT TRANSITION TEAM

For a standard equipment type application, request the supplier to

3.5 Data and Security

JOINT EQUIPMENT TRANSITION TEAM

State the system of measurement that will be used

3.5.4 Interface with Other Equipment

JOINT EQUIPMENT TRANSITION TEAM

by ________ inches with at least a _______inch

3.6.2.1.1 Room will be non-hazardous

3.6.2.1.2 Room will be Class I Div II (Zone 2)

3.6.2.1.3 Room will be Class I Div I (Zone 1)

3.6.2.2.1 ISO Class 5, 7, or 8 (ISO 14644-1 and ISO

3.6.2.2.2 Class A, B, C, or D (The Rules Governing

3.6.2.2.3 Directional airflow

3.6.2.2.4 Airflow velocity

3.6.2.2.5 Number of air changes

3.6.2.2.6 Particle Ingress

JOINT EQUIPMENT TRANSITION TEAM

3.6.2.4 Rating of enclosures

JOINT EQUIPMENT TRANSITION TEAM

JETT EQUIPMENT ACQUISITION MODEL

Equipment Validation Plan/ Engineering Feasibility Study

Approval Detailed Design

Approval System Acceptance Test

Review System • Hardware • Software

JOINT EQUIPMENT TRANSITION TEAM

4.2 Equipment Constraints

4.3 Compatibility and Support

JOINT EQUIPMENT TRANSITION TEAM

licensing of the custom code for the life of the

JOINT EQUIPMENT TRANSITION TEAM

4.3.3.5.1 ______ VAC ____ Hertz

4.3.3.5.4 Uninterruptible Power Supply (Define

4.5 Procedural Constraints

JOINT EQUIPMENT TRANSITION TEAM

Stainless Steel, 304 Stainless Steel, etc.)

JOINT EQUIPMENT TRANSITION TEAM

4.6.1.1 System shall be maintained on a schedule as indicated by

by __ inches with at least a _inch

4.3.3.5.1 __ VAC Hertz

• Instrument Listing Microsoft Word XX (.doc) or Excel XX (.xls)

• Bill of Materials Microsoft Word XX (.doc) or Excel XX (.xls)

• Spare Parts List Microsoft Word XX (.doc) or Excel XX (.xls)

• Component Cut Sheets Microsoft Word XX (.doc) or Excel XX (.xls)