REVISION HISTORY
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
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.
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:
3.4.2.1.1 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
4.0 CONSTRAINTS
4.1 Milestones and Timelines
Based on the model outlined below, establish the project milestones with a
timeline:
4.3.3.4.1 Volume
4.3.3.4.2 pH
4.3.3.4.3 Temperature
4.3.3.4.4 Materials
4.3.3.5 Electricity
4.3.3.5.2 Phases
4.3.3.5.3 Amperage
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].
4.6 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.
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.
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.
JOINT EQUIPMENT TRANSITION TEAM
USER REQUIREMENTS Page 20 of 25
Doc ID: BLANK URS
RAJA SPECIFICATION
TEMPLATE Rev.3
BLANK TEMPLATE June 2018
• CONTROL PLATFORM Program Printout and Disk File XXX Program Development format
• OIP Configuration Printout and Disk File XXX Program Development format
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
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
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
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.
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.
9.0 ATTACHMENTS