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JETT USER REQUIREMENTS

SPECIFICATION

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JOINT EQUIPMENT TRANSITION TEAM

USER REQUIREMENTS TEMPLATE

FOR A SYSTEM

(INSERT YOUR SYSTEM DESCRIPTION HERE)


SPECIFICATION

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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)


SPECIFICATION

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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:

Alarm or Informational Message Critical

Alarm

Stackpole Light

Illumination

(color/flashing)

Informational

Message

Response

Interlock(s) Operator

Procedural

Emergency Stop X X

Control Platform Communication

Watchdog X X

Control Power Fault X X

Main Air Fault X X

XXXX X

YYYY X

ZZZZ X

Motor Faults X X

CONTROL PLATFORM Battery Low

Warning X X

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:

Integrate with Validation

Documentation as appropriate

JJEETTTT EEQQUUIIPPMMEENNTT AACCQQUUIISSIITTIIOONN MMOODDEELL

SUPPLIER

Functional

Specification

USER/(CONSULTANT if applicable)

Master Validation Plan

RFQ

User Audit

Proposal

• Project Plan • Quality & Validation Plan

Equipment Validation Plan/

Risk Assessment

• Explanation to Supplier

User Requirements

Specification

(Living Document)

Proposal Analysis

Proposal

P.O.

Detailed Design

Documentation (traceable to Functional Specification)

Review Functional Specification

Review Detailed Design

System Acceptance Test

Specifications (IQ/OQ)

• Hardware • Software

Review System

Acceptance Test Specifications

System Acceptance

Testing and Results

User Witness Optional

Maintenance & Support

Documentation

Approval

Approval

Approval

Engineering Feasibility Study

and Results P.O.


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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


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level that is comprehensible to a high school graduate.

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


SPECIFICATION

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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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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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