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									                                      Page 1 of 22
           USER REQUIREMENTS
                                   Doc ID: USP 25 Water
JETT         SPECIFICATION
                                    System URS Rev.B1
            USP 25 Water System
                                      October 2002

       USER REQUIREMENTS TEMPLATE
          for a USP Water System




       JOINT EQUIPMENT TRANSITION TEAM
                                                                  Page 2 of 22
                           USER REQUIREMENTS
                                                               Doc ID: USP 25 Water
       JETT                  SPECIFICATION
                                                                System URS Rev.B1
                           USP 25 Water System
                                                                  October 2002

                           REVISION HISTORY

Rev.    Date      Approval   Revision Summary
A1     03/05/02    Draft     Format revisions
A2     02/27/02    Draft     Draft for review
A3     04/18/02    Draft     Second content review
A4     08/15/02    Draft     Third content review
A5     09/03/02    Draft     Fourth content review
A6     10/10/02    Draft     General document cleanup following the fourth content review
B1      01/24-      MJC      Validation Review
          03




                  JOINT EQUIPMENT TRANSITION TEAM
                                                                                                 Page 3 of 22
                                    USER REQUIREMENTS
                                                                                            Doc ID: USP 25 Water
      JETT                            SPECIFICATION
                                                                                             System URS Rev.B1
                                     USP 25 Water System
                                                                                                October 2002

                                      TABLE OF CONTENTS
1.0       INTRODUCTION.............................................................................................. 4
2.0       OVERVIEW ....................................................................................................... 5
3.0   OPERATIONAL REQUIREMENTS .............................................................. 6
  3.1  REVERSE OSMOSIS EQUIPMENT ..................................................................... 6
  3.2  DEIONIZATION (POLISHING) EQUIPMENT ...................................................... 6
  3.3  FUNCTIONS ...................................................................................................... 7
  3.4  DATA AND SECURITY ....................................................................................... 9
  3.5  ENVIRONMENT............................................................................................... 11
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 ................................................................................................... 17
  5.1   DEVELOPMENT .............................................................................................. 17
  5.2   TESTING ......................................................................................................... 18
  5.3   DELIVERY ...................................................................................................... 18
  5.4   SUPPORT ........................................................................................................ 19
6.0       GLOSSARY...................................................................................................... 21
7.0       REFERENCES ................................................................................................. 21
8.0       APPROVAL ..................................................................................................... 22




                        JOINT EQUIPMENT TRANSITION TEAM
                                                                        Page 4 of 22
                         USER REQUIREMENTS
                                                                   Doc ID: USP 25 Water
   JETT                    SPECIFICATION
                                                                    System URS Rev.B1
                          USP 25 Water System
                                                                      October 2002

Project No.:
Insert the unique project number associated with this particular URS.

Document No.:
Insert the Document Identification Number and Revision.

Document Description:
This document describes the user requirements for a water system designed to produce
USP quality water in accordance with the current requirements. This document
includes requirements only for reverse osmosis (RO) and post RO polishing utilizing
mixed bed deionization. This document assumes that the water supplied to the RO has
been appropriately treated based on feedwater characteristics. Note that this document
describes a typical water purification regime however; there are various methods of
producing USP quality water that should also be considered.


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 attached Equipment Validation Plan that outlines the Supplier’s
       responsibilities .
       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.




                 JOINT EQUIPMENT TRANSITION TEAM
                                                                       Page 5 of 22
                          USER REQUIREMENTS
                                                                    Doc ID: USP 25 Water
   JETT                     SPECIFICATION
                                                                     System URS Rev.B1
                           USP 25 Water System
                                                                       October 2002

2.0    OVERVIEW
This document describes the overall requirements needed to manufacture a Purified
Water system designed to produce            (insert requirements here) US gallons/min (
         liters/min) USP25 grade water for use in the processing of pharmaceutical
products. The design of the system shall ensure proper operation including all
interlocks, programming, sampling ports, valving, and equipment and interconnecting
piping and wiring. The water produced must meet all requirements detailed under the
USP 23 for use at the points of use. Reverse Osmosis and Deionization shall be used
to ensure water quality meets or exceeds all stated requirements. The User may wish to
consider additional methods of deionization (polishing) for example, electro-
deionization. The equipment shall be designed for continuous (or intermittent) usage.
A more detailed explanation of the method of operation of the RO unit and its relation
to the DI units would be helpful. Similarly a brief overview of the DI units would help.
As commented elsewhere, the level of detail in this URS is significantly different to
others I have reviewed. I think it needs to go back to the development team. However,
since it has been through several reviews, you may not want to change it. I have
difficulty stating that this document has been revierwed for validation suitability at this
point so I have not incremented the revision level. MJC

Note to editor: you should also consider plant standards, feedwater quality, and source
before determining the method used to manufacture water to the USP requirements.
The system included here includes only reverse osmosis and deionization processing
equipment. It is assumed that the appropriate pretreatment to allow proper operation
of the RO has been considered (softening, filtration, bacterial control) as well as the
appropriate storage and distribution system downstream of the RO/DI equipment.
Refer to the diagram below. Area shaded in diagram is not included within the scope
of this URS.




                  JOINT EQUIPMENT TRANSITION TEAM
                                                                      Page 6 of 22
                        USER REQUIREMENTS
                                                                  Doc ID: USP 25 Water
  JETT                    SPECIFICATION
                                                                   System URS Rev.B1
                         USP 25 Water System
                                                                     October 2002

                       Purified Water Generation Diagram


3.0   OPERATIONAL REQUIREMENTS

      3.1   Reverse Osmosis Equipment
      The reverse osmosis unit shall provide --       US gpm of product water based on
      a feed temperature of           C. The reverse osmosis system shall include a
      prefilter with pre- and post- unit pressure gauges. The system shall operate with
      a 50 to 75 percent recovery with an initial salt rejection of greater than        %. (98% is typical;

      Appropriate sampling ports shall be included on the RO system.

      Appropriate monitors shall be included to ensure proper operation of the
      system.

      For example: (edit as required) The feed water shall be monitored locally for
      pressure, conductivity, temperature and flow. The reject water is monitored
      locally for pressure and flow. The unit shall monitor reject recirculation,
      product, and conductivity.


      3.2   Deionization (Polishing) Equipment
      The Deionization (DI) Recirculation loop shall maintain water quality and flow
      through DI cylinders during periods of no demand from the storage tank and
      ensure adequate flow through the loop. The loop is monitored for example (edit
      as needed) water resistivity, temperature and pressure. An automatic valve is
      provided for bleeding to drain during flushing and high temperature conditions.
      A set of automatic valves are provided to allow for filling the tank or putting the
      loop into recirculation.

      Recirculation pump will be centrifugal type. The pump will have a typical flow
      of     usgpm @       psi.

      Mixed Bed Deionization cylinders shall be designed for continuous operation
      and to provide flow of _ us gpm during operation.

      Notes to editor: consider peak and average flow rate requirements. You may
      also want to consider a resin specification. For example: Resin to meet TOC
      requirements prior to installation.



                JOINT EQUIPMENT TRANSITION TEAM
                                                                 Page 7 of 22
                    USER REQUIREMENTS
                                                              Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                               System URS Rev.B1
                     USP 25 Water System
                                                                 October 2002

 This will provide a capacity of                gallons of Purified Water USP per
 regeneration based on RO quality of            µS.


 3.3   Functions

       3.3.1   Operation
               The system shall operate with a minimum of operator involvement.
               Operation shall be safe from an operator and environmental
               standpoint.
               The system shall be operated locally at the equipment itself.
               Manual and automatic control is required for proper operation.

       3.3.2   Power failure/Recovery
               In the event of a power failure, the system shall protect in the
               following priority:
                   Personnel
                   Equipment
                   Product
               Recovery Methods:
               For example:
                   Manually re-start based on operator inputs (Operator initiates
                    power recovery sequence) in the event of prolonged power
                    outage.
                   Re-start based on last state before loss of power. (System
                    runs through power recovery sequence when operator start
                    signal is given, including flush-up to required minimum
                    water quality)
                   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).

       3.3.3   “Emergency Stop”
               For example:



           JOINT EQUIPMENT TRANSITION TEAM
                                                                               Page 8 of 22
                                   USER REQUIREMENTS
                                                                           Doc ID: USP 25 Water
           JETT                      SPECIFICATION
                                                                            System URS Rev.B1
                                   USP 25 Water System
                                                                              October 2002

                              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 local safety standards. The E-Stop design
                              shall allow the equipment to return to a “safe” condition, including
                              the venting of pressure as required.

                      3.3.4   Alarms and Warnings
                              “Critical alarms” - Insert your specific “Critical Alarm” action
                              scheme here.
                              For example:
                              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 reset and the
                              system restarted. Once the alarm is reset, the operator may restart
                              the system.
                              “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:
                              The Equipment shall have the following critical alarms and
                              warnings:
                                                          Non-                                 Response
                                             Critical                 Informational
   Alarm or Informational Message                        Critical                                    Operator
                                             Alarm                       Message       Interlock(s)
                                                         Alarm                                      Procedural
Emergency Stop                                  X                                           X
Control Platform Communication
                                                X                                             X
Watchdog
Control Power Fault                             X                                             X
Main Air Fault                                  X                                             X
Over Pressure Alarm                             X                                             X
Permeate Quality Low                                        X                                 X         X
Feedwater Pressure Low                          X                                             X



                          JOINT EQUIPMENT TRANSITION TEAM
                                                                               Page 9 of 22
                                 USER REQUIREMENTS
                                                                          Doc ID: USP 25 Water
           JETT                    SPECIFICATION
                                                                           System URS Rev.B1
                                  USP 25 Water System
                                                                               October 2002

                                                         Non-                                 Response
                                           Critical                 Informational
   Alarm or Informational Message                       Critical                                    Operator
                                           Alarm                       Message        Interlock(s)
                                                        Alarm                                      Procedural
Tank Level High                                            X                               X
Tank Level Low                                             X                                           X
Tank Level Low-Low                             X                                              X
Motor Faults                                   X                                              X
CONTROL PLATFORM Battery Low
                                                           X               X                           X
Warning


                             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 non-critical”
                             criterions were determined.Informational Messages
                             “Informational Messages” shall notify the operator and take no
                             further action.

               3.4   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. The supplier shall stipulate the methods by which
                     this criterion is met.

                     3.4.1   User Interfaces
                             This section should address the following issues:
                                 Operator interface access levels
                                 Frequency of data point collection
                                 Hardcopy/electronic data collection requirements
                                 Compliance with 21CFR Part 11 (for Europe - EREC
                                    Guidelines)
                                 Data retention time on the system
                                 Data storage media


                         JOINT EQUIPMENT TRANSITION TEAM
                                                                Page 10 of 22
                    USER REQUIREMENTS
                                                             Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                              System URS Rev.B1
                    USP 25 Water System
                                                                October 2002

               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.),
               etc.).

       3.4.2   User Interface with Supervisors and Operators
               example:
               The CONTROL PLATFORM system shall include interfaces with
               the Operator and Supervisor that ensures easy, safe, and reliable
               operation.
               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.

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

               3.4.2.2    Displayed Requirements:
                          State the system of measurement that will be used
                          (English or Metric (SI)).

                     Parameter                 Format         Unit(s) of measurement
                Feedwater                      XXX.X          Degrees C or Degrees F
                Temperature
                Pressure                       XXX.X          Psig or Bar
                Permeate Quality               XX.X           MicroSiemens or
                                                              Megohm/cm
                Feedwater Quality               XX.X          MicroSiemens or
                                                              Megohm/cm
                Recovery                        XX.X          Percentage
                Permeate Flowrate               XX.X          LPM or GPM

       3.4.3   Security Levels
               List the total number of different access levels that will be
               required. Provide a general description of the access rights for



           JOINT EQUIPMENT TRANSITION TEAM
                                                                Page 11 of 22
                    USER REQUIREMENTS
                                                             Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                              System URS Rev.B1
                    USP 25 Water System
                                                                October 2002

               each level (screen navigation, operational control, control loop
               variable manipulation, alarm setpoint manipulation, etc.).

       3.4.4   Interface with Other Equipment
               The control system shall include the interfaces necessary to
               facilitate operation and configuration. For example:
                         An RS-232 communications port shall be provided.
                         A Modem communications port shall be provided.
                         A high-speed configuration/monitoring connection
                          shall be provided.

       3.4.5   Data Collection
               Consider any archiving and reporting requirements here.
                   None
                   Recorder
                   Process Printout
                   Electronic process printout, Historical Trending
                   Electronic process printout, Historical Trending and interface
                    to company network


               The following shall be recorded:
                   Feedwater Temperature
                   Pressure
                   Permeate Quality
                   Feedwater Quality
                   List all parameters that are required to be recorded.

 3.5   Environment
       Provide details of the physical environment in which the
       [equipment/system] will be operated.
       3.5.1   Layout
               For example:




           JOINT EQUIPMENT TRANSITION TEAM
                                                              Page 12 of 22
                  USER REQUIREMENTS
                                                           Doc ID: USP 25 Water
JETT                SPECIFICATION
                                                            System URS Rev.B1
                   USP 25 Water System
                                                              October 2002

                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.
                See attached drawing #________________________ (if
                 applicable).
             Layout is specific to the size equipment being used and system
             requirements of the equipment.

                Rating of enclosures
                 List the rating requirements for enclosures in the environment.
                    NEMA 1 (Open)
                    NEMA 12 (Oil tight)
                    NEMA (Washdown)
                    NEMA 4X (Washdown and non-Corrosive)

       3.5.2 Sanitization Requirements
             Describe the type of sanitization that will be performed on or
             within the [equipment/system] and the duration the
             [equipment/system] will be exposed. Include any CIP skid
             requirements, if appropriate.
       3.5.3 Intended Operating Environment:
             Describe the type of operating environment that the
             [equipment/system] will be exposed to following installation.
             For example:
             The [equipment/system] shall be mounted in a utility 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>.




           JOINT EQUIPMENT TRANSITION TEAM
                                                                       Page 13 of 22
                            USER REQUIREMENTS
                                                                   Doc ID: USP 25 Water
  JETT                        SPECIFICATION
                                                                    System URS Rev.B1
                             USP 25 Water System
                                                                       October 2002


4.0   CONSTRAINTS

      4.1     Milestones and Timelines
              Use one of the two schedule outlines provided below. Delete the schedule
              not selected for use. Fill in time scales or dates as appropriate and
              add/delete items as applicable. If available, refer to the user’s project
              schedule to assist with this area. An agreed upon timeline may be
              referenced here and attached as an appendix.
              The parties involved should submit a basic timeline as outlined below:



                             “BASELINE” EQUIPMENT ACQUISITION MODEL
            USER/(CONSULTANT if applicable)                              SUPPLIER
                Master Validation Plan                                  User Audit of Supplier
                                                                               • User Initiates

                Equipment Validation Plan            RFQ
                  • Explanation to Supplier
                                                                              Proposal
                    (Living Document)               RFQ                    • Quality Plan
            User Requirements Specification (URS)        osal              • Project Plan
                                                      op
                     (Living Document)              Pr

                                                       P.O.             Functional Specification
                     Proposal Analysis                                      (Traceable to URS)


                                                    Approval              Detailed Design
               Review Functional Specification                            Documentation
                                                                (traceable to Functional Specification)

                                                    Approval
                    Review Detailed Design                              System Acceptance Test
                                                                        Specifications (IQ/OQ)
                                                                              • Hardware
                                                                              • Software
                      Review System
                                                    Approv
               Acceptance Test Specifications             al            System Acceptance
                                                                        Testing and Results
                                                                      (User Witness Optional)
                   Integrate with Validation
                Documentation (as appropriate)                        Maintenance & Support
                                                                         Documentation




                   JOINT EQUIPMENT TRANSITION TEAM
                                                               Page 14 of 22
                   USER REQUIREMENTS
                                                            Doc ID: USP 25 Water
JETT                 SPECIFICATION
                                                             System URS Rev.B1
                      USP 25 Water System
                                                               October 2002


 4.2   Equipment Constraints
       Describe the operating constraints that the [equipment/system] will be
       required to meet.
       For example:
       4.2.1   Environmental Conditions
               The [equipment/system] is to be used at the following
               environmental conditions:
               Altitude ________ ft above sea level
       4.2.2   Equipment Generated Vibration
               The maximum allowable equipment vibration generated during
               operation is <value>.

 4.3   Compatibility and Support
       Include any requirements for compatibility with other User systems. In
       the examples provided below, fill in blanks with the appropriate
       information. Delete areas that are not applicable to this application.
       4.3.1   CONTROL PLATFORM Controllers
               The Supplier shall utilize             Control Platform
               Controllers that shall include a communications port.
               The Supplier shall provide documentation that the program
               (embedded software) was developed and coded utilizing
                        program development and documentation software.
               The supplier shall indicate the use of custom or “bespoke” code
               within the equipment, and shall supply licensing of the custom
               code for the life of the equipment.
               An escrow agreement shall be required in the event the supplier
               cannot support the supplied custom software any longer. In such
               instances, the source code and all information regarding the source
               code shall be given to the user in a timely fashion to prevent
               downtime of the equipment.
       4.3.2   Preferred Vendor List
               If necessary attach any critical preferred vendors. Refrain from
               driving the supplier into customizing his equipment package.




           JOINT EQUIPMENT TRANSITION TEAM
                                                                 Page 15 of 22
                    USER REQUIREMENTS
                                                              Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                               System URS Rev.B1
                     USP 25 Water System
                                                                 October 2002

       4.3.3   Utilities
               The utilities and space involved needs to be discussed prior to
               purchasing the equipment. Obviously, the actual equipment size is
               but a small part of the entire scope of work necessary to implement
               a larger system. The unit and its support equipment must be able to
               be installed in current building facilities.
               The User shall ensure that the following utilities are available and
               that the utility supply lines and piping are terminated with fittings
               or connections, which are compatible with those described on the
               Customer Connection Drawings.
               The Supplier shall specify utility data, which is marked with a
               triangle. Utility data, which are not specified or marked with a
               triangle, shall be brought to the attention of the User. These data
               shall be specified (by the User or the Supplier) and shall be
               approved by both the User and the Supplier before system design
               begins.
                     Base Utilities Worksheet
                           Related Discharges
                              Volume
                              pH
                              Temperature
                           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 equipments, unless
                                specified.



           JOINT EQUIPMENT TRANSITION TEAM
                                                                 Page 16 of 22
                    USER REQUIREMENTS
                                                              Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                               System URS Rev.B1
                      USP 25 Water System
                                                                 October 2002

                         Other Utility Requirements
                            Provide details regarding any other utility systems
                            that are required to support operation of the
                            equipment/system.

 4.4   Availability
       The [equipment/system] is intended to be operated <Continuously,
       Regularly, __ hours per day, __ hours per week>.

       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>.

 4.5   Procedural Constraints
       4.5.1   Product Contact Materials
               Describe any local procedural requirements such as local
               standards, which must be adhered to if applicable.
               For example: All piping welds and product contact welds shall
               meet ASME and 3A specification requirements. Product contact
               metal to be (316L Stainless Steel, 316 Stainless Steel, 304
               Stainless Steel, etc.)
               List critical requirements for surface finish, roughness, etc.
               Other standards are attached. The Supplier shall adhere to the
               indicated sections only.
       4.5.2 Product in Contact with Materials
               All product contact parts should be considered.

       4.5.3 Noise Level Constraints
               Insert your own noise level constraint requirements here.

               For example:

               The noise level generated during operation of the
               [equipment/system] will not exceed 85 DB from 3 feet away.




           JOINT EQUIPMENT TRANSITION TEAM
                                                                    Page 17 of 22
                        USER REQUIREMENTS
                                                                 Doc ID: USP 25 Water
  JETT                    SPECIFICATION
                                                                  System URS Rev.B1
                         USP 25 Water System
                                                                    October 2002

            4.5.4   EMI / RFI levels are:
                    Insert your own electrical and radio noise immunity requirements
                    here.

                    For example:

                    The [equipment/system] [will/will not] be used in an area where
                    two-way radio communication devices are in operation. The
                    [equipment/system] shall meet CE requirements for electrical noise
                    immunity and emissions.


      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.

            System shall be maintained on a schedule as indicated by the supplier.
            Supplier is to provide (at minimum) the following maintenance
            instructions:
                   All sub-systems provided (Maintenance and operation manuals
                      of vendor equipment)
                   A comprehensive lubrication list and recommended lubrication
                      schedule
                   A comprehensive recommended maintenance (regular
                      recommended inspection intervals, wear points, recommended
                      spare parts list)
                   Supplier shall supply ______ Copies of Operation, Installation,
                      Maintenance and de-commissioning manuals

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 User’s review.



                JOINT EQUIPMENT TRANSITION TEAM
                                                               Page 18 of 22
                   USER REQUIREMENTS
                                                            Doc ID: USP 25 Water
JETT                 SPECIFICATION
                                                             System URS Rev.B1
                    USP 25 Water System
                                                                October 2002

       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.

 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
               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.




           JOINT EQUIPMENT TRANSITION TEAM
                                                                            Page 19 of 22
                                 USER REQUIREMENTS
                                                                         Doc ID: USP 25 Water
        JETT                       SPECIFICATION
                                                                          System URS Rev.B1
                                 USP 25 Water System
                                                                            October 2002

                            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:
   Project Plan                                               Microsoft Word 97 (*.doc)

   User Requirements Specification                            Microsoft Word 97 (*.doc)

   Functional Specification/Requirement                       Microsoft Word 97 (*.doc)

   Design Specifications                                      Microsoft Word 97 (*.doc)

   Controls Test                                              Microsoft Word 97 (*.doc)

   Hardware Installation Test                                 Microsoft Word 97 (*.doc)

   Operational Test                                           Microsoft Word 97 (*.doc)

   Factory Acceptance Test                                    Microsoft Word 97 (*.doc)

   Operator, Maintenance and Service Manuals                  Microsoft Word 97 (*.doc)

   Process and Instrumentation Diagram (P&ID)                 AutoCAD version 12.0 (*.dxf)

   Instrument Listing                                         Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

   Control Schematics                                         AutoCAD version 12.0 (*.dxf)

   Control Panel Assembly Drawings                            AutoCAD version 12.0 (*.dxf)

   Equipment Assembly Drawings                                AutoCAD version 12.0 (*.dxf)

   Bill of Materials                                          Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

   Spare Parts List                                           Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

   Component Cut Sheets                                       Microsoft Word 97 (*.doc) or Excel 97 (*.xls)

   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.




                         JOINT EQUIPMENT TRANSITION TEAM
                                                                 Page 20 of 22
                    USER REQUIREMENTS
                                                              Doc ID: USP 25 Water
JETT                  SPECIFICATION
                                                               System URS Rev.B1
                     USP 25 Water System
                                                                 October 2002

       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
                         Telephone (Voice or Modem)
                         Replacement Parts Availability List (Normal lead times
                         shall be listed)

               5.4.2.2   User Site Support
                         Preventative Maintenance (list maintenance contracts
                         available)
                         System Improvements (supplier shall notify user of any
                         improvements available on a regular basis)




           JOINT EQUIPMENT TRANSITION TEAM
                                                                      Page 21 of 22
                        USER REQUIREMENTS
                                                                   Doc ID: USP 25 Water
  JETT                    SPECIFICATION
                                                                    System URS Rev.B1
                         USP 25 Water System
                                                                      October 2002


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. Examples are User’s project schedule, the GAMP guide, etc.




                JOINT EQUIPMENT TRANSITION TEAM
                                                                   Page 22 of 22
                         USER REQUIREMENTS
                                                                Doc ID: USP 25 Water
   JETT                    SPECIFICATION
                                                                 System URS Rev.B1
                          USP 25 Water System
                                                                   October 2002


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.



Printed/Typed Name                      Signature                                  Date




This document has been reviewed by the User Quality Assurance Group and approved for
use by the Supplier.



Printed/Typed Name                      Signature                                  Date




This document has been reviewed by the Supplier Project Manager and approved for use by
the Supplier Project Team.



Printed/Typed Name                      Signature                                  Date




Other approvals as necessary may be included, such as the Technical Services Groups,
User Groups, Engineering, etc. as required.




                     JOINT EQUIPMENT TRANSITION TEAM

								
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