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JETT URS TemplateContents
JETT URS TemplateContents
URS Contents
JETT Blank Template
Doc ID: Blank Template URS Contents
Revision 0
Revision Issued - June 2004
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:
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/).
REVISION HISTORY
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.
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
3.4 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
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:
3.6 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 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.