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The URS contents template is designed to be used in conjunction with the URS blank template
developed by the Joint Equipment Transition Team (JETT) in accordance with current GAMP
guidance. The numbering system used in the URS contents template match the sections by number
in the JETT URS blank template. The URS contents template only includes the following sections:
1.0
2.0
3.0

Introduction (Scope)
Overview
Operational Requirements

The other sections included in the URS blank template are typically boiler-plate and will only
require minimal modification for specific end users.
The electronic versions of the JETT documents (URS contents template and URS blank template)
are available at no cost on the JETT website (http://www.jettconsortium.com/).
The information presented in this URS contents document is designed to be utilized
(cut/pasted) into the current JETT URS template or specific end-user URS templates.

REVISION HISTORY
Rev.

Date

Developed By:

Revision Summary

June 2004

JETT

Initial Release

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 Suppliers 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

2.2

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)
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

3.2

3.3

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

Process Requirements
3.2.1

Quality of products and concentrations

3.2.2

Product limitations (i.e. temperature, humidity, pH, etc.)

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:
3.4.1.4

Manual only

3.4.1.5

Manual/automatic

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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:

3.4.2.2

3.4.2.1.1

Personnel

3.4.2.1.2

Equipment

3.4.2.1.3

Product

Recovery Methods: Insert your specific recovery scheme here.

For example:

3.4.3

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).

Emergency Stop
Insert your specific Emergency Stop (E-Stop) strategy and communication
scheme here.
For example:
4.1.1

3.4.4

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.

Alarms and Warnings

3.4.4.1

Critical alarms - Insert your specific Critical 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

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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

Alarm or Informational Message

Critical
Alarm

The Equipment shall have the following critical

alarms and warnings:
Stackpole
Light
Illumination
(color/flashin
g)

Response
Information
al Message

Interlock(s)

Emergency Stop

Control Platform Communication

Watchdog

Control Power Fault

Main Air Fault

Operator
Procedural

XXXX

YYYY

ZZZZ

Motor Faults

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.
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
3.5.1.2

User interface access levels

Frequency of data point collection

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3.5.1.3
3.5.1.4
3.5.1.5
3.5.1.6

3.5.2

Hardcopy/electronic data collection requirements

Compliance with 21CFR Part 11 (for Europe - EREC Guidelines)
Data retention time on the system
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.).

User Interface with Supervisors and Operators

Insert your interface scheme here.
For example:

3.5.3

1.1

The CONTROL PLATFORM system shall include interfaces with the

Operator and Supervisor that ensures easy, safe, and reliable
operation.

1.2

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.

Language requirements
Specify language that information will be displayed in (i.e. English, Spanish,
German, Bilingual, etc.)
3.5.3.1

Displayed Requirements:
State the system of measurement that will be used (English or
Metric (S.I.)).
Parameter

3.5.4

Format

Unit(s) of measurement

XXXXXXX

(###.#) units

units

YYYYYYY

(##)%

Interface with Other Equipment

The control system shall include the interfaces necessary to facilitate
operation and configuration. For example:
3.5.4.1
3.5.4.2
3.5.4.3

3.5.5

An RS-232 communications port shall be provided.

A Modem communications port shall be provided.
A high-speed configuration/monitoring connection shall be
provided.
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.).

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3.5.6

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Data Collection
Consider any archiving and reporting requirements here.
3.5.6.1
3.5.6.2
3.5.6.3
3.5.6.4
3.5.6.5

None
Recorder
Process Printout
Electronic process printout, Historical Trending
Electronic process printout, Historical Trending and interface to
company network
The following shall be recorded:
3.5.6.6
3.5.6.7
3.5.6.8
3.6

XXXXX
YYYYY
ZZZZZ

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

3.6.2

Allocated floor space for the equipment is _____ inches 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.
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

3.6.2.2

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

atmosphere present at all times)
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 146442)

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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

3.6.2.3

Particle Ingress
Biohazard Level
List the critical biohazard level requirements for the environment.

3.6.2.4

3.6.3

3.6.4

3.6.2.3.1

BL-1

3.6.2.3.2

BL-2

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)

Cleaning Requirements
3.6.3.1

Hand-Wash

3.6.3.2

Auto-Wash

3.6.3.3

Steam Clean

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

3.6.5.2
3.6.5.3

The [equipment/system] shall be mounted in a GMP environment

with a temperature range of 15 to 25 C, non-condensing
humidity.
Vibration levels in operating environment are <Negligible, Slight,
or Severe>
The Seismic Zone in the operating environment is <Zone 1, Zone
2, Zone 3, Zone 4, or Zone 4A>.

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