Professional Documents
Culture Documents
Urs Template Contents
Urs Template Contents
URS Contents
JETT
Blank Template
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
URS Contents
JETT
Blank Template
Page 2 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
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
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.
2.2
URS Contents
JETT
Blank Template
Page 3 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
3.2
3.3
Capacity
3.1.1
Range of products
3.1.2
3.1.3
3.1.4
Production rates
Process Requirements
3.2.1
3.2.2
Process Control
3.3.1
Measurement Range
3.3.2
Setpoint Range
3.3.3
3.4
Functions
3.4.1
Operation
Enter your specific operational requirements here.
3.4.1.1
3.4.1.2
3.4.1.3
Manual only
3.4.1.5
Manual/automatic
URS Contents
JETT
Blank Template
3.4.2
Page 4 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
Power failure/Recovery
3.4.2.1
3.4.2.2
3.4.2.1.1
Personnel
3.4.2.1.2
Equipment
3.4.2.1.3
Product
3.4.3
3.4.2.2.1
3.4.2.2.2
3.4.2.2.3
Emergency Stop
Insert your specific Emergency Stop (E-Stop) strategy and communication
scheme here.
For example:
4.1.1
3.4.4
3.4.4.1
3.4.4.1.1
Page 5 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
URS Contents
JETT
Blank Template
3.4.4.2
3.4.4.2.1
Critical
Alarm
Response
Information
al Message
Interlock(s)
Emergency Stop
Operator
Procedural
XXXX
YYYY
ZZZZ
Motor Faults
X
X
User Interfaces
This section should address the following issues:
3.5.1.1
3.5.1.2
Page 6 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
URS Contents
JETT
Blank Template
3.5.1.3
3.5.1.4
3.5.1.5
3.5.1.6
3.5.2
3.5.3
1.1
1.2
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
(##)%
3.5.5
URS Contents
JETT
Blank Template
3.5.6
Page 7 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
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
3.6.2.1.1
3.6.2.1.2
3.6.2.1.3
3.6.2.2
3.6.2.2.1
URS Contents
JETT
Blank Template
Page 8 of 8
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
3.6.2.2.2
3.6.2.2.3
Directional airflow
3.6.2.2.4
Airflow velocity
3.6.2.2.5
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
3.6.2.4.3
3.6.2.4.4
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
3.6.5.2
3.6.5.3