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End User Requirements Template - DOC

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End User Requirements Template document sample

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									                                                                                   Page 1 of 8
                                 URS Contents                         Doc ID: Blank Template URS Contents
   JETT                             Blank Template                                 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:

                   1.0    Introduction (Scope)
                   2.0    Overview
                   3.0    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
               0           June 2004           JETT                  Initial Release




1.0     INTRODUCTION (SCOPE)
        Note: Insert your own description and introduction. You may wish to include your own
        requirements and specifics to provide the inexperienced reader, contractors, and suppliers
        an 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 Supplier’s 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.



                         JOINT EQUIPMENT TRANSITION TEAM
                                                                                Page 2 of 8
                              URS Contents                         Doc ID: Blank Template URS Contents
  JETT                        Blank Template                                    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     Use: Describe what applications the equipment/system will be used to support.
              Include a brief explanation of the general functions.
              For example (for a Wide Range Filler):
              2.1.1   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.
              For equipment dealing with solid dosage pharmaceutical products directly:
              2.1.1   The products being developed on the specified equipment are of:
                      2.1.1.1 Low active (vitamins, supplements)
                      2.1.1.2 Medium active (e.g. Aspirin)
                      2.1.1.3 Highly active (e.g. Morphine)
                      2.1.1.4 Exclusive (e.g. Penicillin)
      2.2     Capacity: Provide a brief description of the equipment/system capacity
              requirements.
              For example (for a Wide Range Filler):
              2.2.1   The equipment shall be capable of producing XYZ product continuously,
                      over an 8-hour shift.




                   JOINT EQUIPMENT TRANSITION TEAM
                                                                                 Page 3 of 8
                              URS Contents                          Doc ID: Blank Template URS Contents
  JETT                          Blank Template                                   Revision 0
                                                                         Revision Issued - June 2004



3.0   OPERATIONAL REQUIREMENTS
      This Section shall state the operational requirements: system functions, data and interfaces.
      It shall also define the environment in which the system must operate. Critical
      requirements shall be specifically identified as such. Include process descriptions and
      flowcharts as appropriate.

      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

      3.2   Process Requirements
            3.2.1   Quality of products and concentrations
            3.2.2   Product limitations (i.e. temperature, humidity, pH, etc.)

      3.3   Process Control
            3.3.1   Measurement Range
            3.3.2   Setpoint Range
            3.3.3   Parameter Control Tolerance
                    Note: At a minimum, list the critical, process parameters. Consider
                    documenting how each of the parameter requirements was determined.

      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




                    JOINT EQUIPMENT TRANSITION TEAM
                                                                           Page 4 of 8
                         URS Contents                         Doc ID: Blank Template URS Contents
JETT                     Blank Template                                    Revision 0
                                                                   Revision Issued - June 2004


       3.4.2   Power failure/Recovery
               3.4.2.1    Power Failure: Insert your specific power failure/recovery scheme
                          here.
                          For example:
                          In the event of a power failure, the system shall protect in the
                          following priority:

                         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:

                         3.4.2.2.1     Manually re-start based on operator inputs (Operator
                                       initiates power recovery sequence).

                         3.4.2.2.2     Re-start based on last state before loss of power.
                                       (System runs through power recovery sequence when
                                       operator start signal is given)

                         3.4.2.2.3     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).
       3.4.3   “Emergency Stop”
               Insert your specific “Emergency Stop” (E-Stop) strategy and communication
               scheme here.
               For example:
               3.4.5.1 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 national and local safety standards.
       3.4.4   Alarms and Warnings
               3.4.4.1    “Critical alarms” - Insert your specific “Critical Alarm” action
                          scheme here.
                          For example:

                           3.4.4.1.1       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


               JOINT EQUIPMENT TRANSITION TEAM
                                                                                               Page 5 of 8
                                         URS Contents                             Doc ID: Blank Template URS Contents
         JETT                            Blank Template                                        Revision 0
                                                                                       Revision Issued - June 2004


                                                            reset and the system restarted. Once the alarm is
                                                            reset, the operator may restart the system.
                               3.4.4.2    “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:

                                           3.4.4.2.1        The Equipment shall have the following critical
                                                            alarms and warnings:
                                                            Stackpole Light                               Response
                                                 Critical                      Informational
       Alarm or Informational Message                         Illumination                                        Operator
                                                 Alarm                            Message       Interlock(s)
                                                            (color/flashing)                                     Procedural
Emergency Stop                                     X                                                X
Control Platform Communication
                                                   X                                                X
Watchdog
Control Power Fault                                X                                                X
Main Air Fault                                     X                                                X
XXXX                                                                                                                    X
YYYY                                                                                                                    X
ZZZZ                                                                                                X
Motor Faults                                       X                                                X
CONTROL PLATFORM Battery Low
                                                                  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 informational message”
                               criterions were determined.

               3.5    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.
                      3.5.1    User Interfaces
                               This section should address the following issues:
                               3.5.1.1    User interface access levels
                               3.5.1.2    Frequency of data point collection
                               3.5.1.3    Hardcopy/electronic data collection requirements


                              JOINT EQUIPMENT TRANSITION TEAM
                                                                           Page 6 of 8
                          URS Contents                        Doc ID: Blank Template URS Contents
JETT                       Blank Template                                  Revision 0
                                                                   Revision Issued - June 2004


               3.5.1.4     Compliance with 21CFR Part 11 (for Europe - EREC Guidelines)
               3.5.1.5     Data retention time on the system
               3.5.1.6     Data storage media
                           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.).
       3.5.2   User Interface with Supervisors and Operators
               Insert your interface scheme here.
               For example:
               3.5.2.1 The CONTROL PLATFORM system shall include interfaces with the
                       Operator and Supervisor that ensures easy, safe, and reliable
                       operation.
               3.5.2.2 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.
       3.5.3   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               Format              Unit(s) of measurement
                XXXXXXX                    (###.#) units           units
                YYYYYYY                    (##)%                   %

       3.5.4   Interface with Other Equipment
               The control system shall include the interfaces necessary to facilitate
               operation and configuration. For example:
               3.5.4.1    An RS-232 communications port shall be provided.
               3.5.4.2    A Modem communications port shall be provided.
               3.5.4.3    A high-speed configuration/monitoring connection shall be
                          provided.
       3.5.5   Security Levels
               List the total number of different access levels that will be required. Provide
               a general description of the access rights for each level (screen navigation,
               operational control, control loop variable manipulation, alarm setpoint
               manipulation, etc.).
       3.5.6   Data Collection
               Consider any archiving and reporting requirements here.


               JOINT EQUIPMENT TRANSITION TEAM
                                                                          Page 7 of 8
                         URS Contents                        Doc ID: Blank Template URS Contents
JETT                     Blank Template                                   Revision 0
                                                                  Revision Issued - June 2004


               3.5.6.1   None
               3.5.6.2   Recorder
               3.5.6.3   Process Printout
               3.5.6.4   Electronic process printout, Historical Trending
               3.5.6.5   Electronic process printout, Historical Trending and interface to
                         company network
               The following shall be recorded:
               3.5.6.6    XXXXX
               3.5.6.7    YYYYY
               3.5.6.8    ZZZZZ

 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.

                           3.6.2.1.1     Room will be non-hazardous

                           3.6.2.1.2     Room will be Class I Div II (Zone 2) (explosive
                                         atmosphere present at known times)

                           3.6.2.1.3       Room will be Class I Div I (Zone 1) (explosive
                                           atmosphere present at all times)
               3.6.2.2    Environmental Classification
                          List the critical air quality requirements for the environment.

                           3.6.2.2.1     ISO Class 5, 7, or 8 (ISO 14644-1 and ISO 14644-
                                         2)




               JOINT EQUIPMENT TRANSITION TEAM
                                                                             Page 8 of 8
                         URS Contents                           Doc ID: Blank Template URS Contents
JETT                     Blank Template                                      Revision 0
                                                                     Revision Issued - June 2004


                           3.6.2.2.2      Class A, B, C, or D (The Rules Governing
                                          Medicinal Products in the European Union –
                                          Annex 1)

                           3.6.2.2.3      Directional airflow

                           3.6.2.2.4      Airflow velocity

                           3.6.2.2.5      Number of air changes

                           3.6.2.2.6   Particle Ingress
               3.6.2.3    Biohazard Level
                          List the critical biohazard level requirements for the environment.
                           3.6.2.3.1      BL-1
                           3.6.2.3.2      BL-2
               3.6.2.4    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      NEMA 12 (Oil tight)
                           3.6.2.4.3      NEMA 4 (Wash down)
                           3.6.2.4.4      NEMA 4X (Wash down and non-Corrosive)
       3.6.3   Cleaning Requirements
               3.6.3.1    Hand-Wash
               3.6.3.2    Auto-Wash
               3.6.3.3    Steam Clean
       3.6.4   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   Intended Operating Environment:
               Describe the type of operating environment that the [equipment/system] will
               be exposed to following installation.
               For example:
               3.6.5.1    The [equipment/system] shall be mounted in a GMP environment
                          with a temperature range of 15 to 25 °C, non-condensing
                          humidity.
               3.6.5.2    Vibration levels in operating environment are <Negligible, Slight,
                          or Severe>
               3.6.5.3    The Seismic Zone in the operating environment is <Zone 1, Zone
                          2, Zone 3, Zone 4, or Zone 4A>.


               JOINT EQUIPMENT TRANSITION TEAM

								
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