Professional Documents
Culture Documents
Upon completion of the template, delete this page prior to updating the Table of
Contents and printing.
1. Many areas of this template have selections or tables that have been prepared
for guidance and ease of template completion. Text in italics is intended to be
used as notes to the User and should be deleted prior to printing. Any options
and/or examples that are not applicable to the specific document being created
should be deleted as well.
2. To update the final Table of Contents, place the cursor inside the shaded area,
press the Right mouse key, and select Update Field.
REVISION HISTORY
TABLE OF CONTENTS
1.0 INTRODUCTION..............................................................................................5
2.0 OVERVIEW........................................................................................................6
3.0 OPERATIONAL REQUIREMENTS...............................................................7
3.1 CAPACITY.........................................................................................................7
3.2 PROCESS REQUIREMENTS...............................................................................7
3.3 PROCESS CONTROL.........................................................................................8
3.4 FUNCTIONS.......................................................................................................8
3.5 DATA AND SECURITY.....................................................................................12
3.6 ENVIRONMENT...............................................................................................14
4.0 CONSTRAINTS...............................................................................................17
4.1 MILESTONES AND TIMELINES.......................................................................17
4.2 EQUIPMENT CONSTRAINTS...........................................................................18
4.3 COMPATIBILITY AND SUPPORT.....................................................................18
4.4 AVAILABILITY................................................................................................21
4.5 PROCEDURAL CONSTRAINTS.........................................................................21
4.6 MAINTENANCE...............................................................................................22
5.0 LIFE-CYCLE....................................................................................................23
5.1 DEVELOPMENT...............................................................................................23
5.2 TESTING..........................................................................................................23
5.3 DELIVERY.......................................................................................................24
5.4 SUPPORT.........................................................................................................25
6.0 GLOSSARY......................................................................................................26
7.0 REFERENCES.................................................................................................27
8.0 APPROVAL.......................................................................................................28
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. Saturated Steam Autoclave for Sterile
Manufacturing Support.
1.0 INTRODUCTION
Note: Insert your own description and introduction. You may wish to include
your own requirements and specifics to allow the inexperienced reader,
contractors, and suppliers 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.
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 the main functions and interfaces. Obviously, technology
improvements and new applications may require deviation from this template.
For example: The autoclave will use saturated steam to sterilize product
contact and critical equipment used in the aseptic formulation and filling
of parenteral drugs. Capacity and/or Critical Attributes: Provide a brief
description of the equipment/system capacity or throughput
requirements or the critical attributes that make it desirable to acquire
the system. (Also reference any industry standards for the autoclave that
are applicable.)
For example: The system must provide, at minimum, the following basic
cycles:
:
Vented Saturated Steam Cycle
1) Heating Phase
2) Exposure Phase
3) Cooling Phase
3.1 Capacity
Describe the range or list specifically the materials,
products or equipment to be sterilized.
- Materials
- Products
- Liquids Vented or Non-Vented
Size of loads.
Describe in detail the requirements for the various steps/phases that are
required. In each phase identify the critical control requirements and
variables that are needed. For example:
Air Removal Phase (if required)
- Range of vacuum (or gravity only)
- Number of vacuum pulses.
- Time to attain vacuum
- Range of vacuum hold time.
- Vacuum level
For the following phases also provide critical control requirements and variables:
Charge Phase
Exposure Phase
Exhaust Phase
Drying Phase (if required)
Vacuum Relief Phase (if required)
3.5 Functions
3.5.1 Operation
Enter your specific operational requirements here.
Basic configurable cycles or phases required.
Number of Cycles
3.5.7 Interlocks
Define the interlocks that are to be supplied with the system. For
example:
3.7 Environment
Provide details of the physical environment in which the
[equipment/system] will be operated. Also note the maximum height,
width and depth that the equipment can be to fit through doorways from
the point where the equipment enters the building to the point of
installation.
3.7.1 Layout
For example: Allocated floor space for the equipment is _____
inches by ________ inches with at least a _______inch corridor
around the periphery for the equipment.
Vertical clearance is _________ inches.
Biohazard Level
List the critical biohazard level requirements for the
environment.
BL-1
BL-2
BL-3
BL-4
Rating of enclosures
List the rating requirements for enclosures in the environment.
NEMA 1 (Open)
NEMA 12 (Oil tight)
NEMA (Wash down)
NEMA 4X (Washdown and non-Corrosive)
3.7.3 Cleaning Requirements
Hand-Wash
Auto-Wash
Sanitization
Steam Clean
4.0 CONSTRAINTS
Related Discharges
Volume
PH
Temperature
Materials
User should indicate the maximum or minimum
volume, pH, temperature, etc. of discharges
Electricity
______ VAC ____ Hertz
Phases
Amperage
Uninterruptible Power Supply (Define Use)
Control Air
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 equipment, unless
specified.
4.4 Availability
The [equipment/system] is intended to be operated <Continuously,
Regularly, __ hours per day, __ hours per week>.
For example:
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.
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 Users review.
The Supplier shall provide a Project Manager for the project to provide a
single communication point with the User.
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.
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.
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.
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 Users receiving
dock.
5.3.1 Documentation
Installation, operation, and maintenance instruction documentation
for the system shall be developed to a level that is comprehensible
to a high school graduate.
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.
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.
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:
User should define format for document transmission (ie. MS Word, Autocad, etc.)
Below is an example:
5.4 Support
Describe what support activities are required after acceptance. The
paragraphs outlined below provide some areas for consideration.
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
Pure Steam Non-condensed WFI
Clean Steam Steam produced from deionized water
Plant Steam Steam used in general plant applications.
Typically contains additives designed to
facilitate condensate collection and reuse.
7.0 REFERENCES
List references that were used in preparing this document or that provide
additional details, such as:
o Equipment Validation Plan
o Current revision of GAMP Guidelines
o Vendor Piping Certification (if applicable)
o Customer Connection Diagram
o Approved Instrumentation List
o Process Flow Diagram
o 21 CFR Part 11
o National Electric Code
o S88
8.0 APPROVAL
Insert your companys 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.