GlasswareWasherURS.doc

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JETT

USER REQUIREMENTS SPECIFICATION

Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

USER REQUIREMENTS TEMPLATE GLASSWARE WASHER

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JETT

USER REQUIREMENTS SPECIFICATION

Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

TABLE OF CONTENTS 1

INTRODUCTION..............................................................................................................6

2

OVERVIEW.....................................................................................................................7

3

OPERATIONAL REQUIREMENTS...................................................................................8 3.1 FUNCTIONS..............................................................................................................8 3.1.1 Items to be cleaned......................................................................................8 3.1.2 Soil Load......................................................................................................8 3.1.3 Cleaning Compounds..................................................................................8 3.1.4 Cleaning Cycle............................................................................................8 3.1.5 Throughput..................................................................................................9 3.1.6 Definition of Satisfactorily Clean................................................................9 3.1.7 Definition of Satisfactorily Dry...................................................................9 3.1.8 Modes of Operation.....................................................................................9 3.1.9 Performance................................................................................................9 3.1.10 Cycle Time...................................................................................................9 3.1.11 Power Failure / Recovery............................................................................9 3.1.12 Emergency Stops........................................................................................10 3.1.13 Safety – Operator......................................................................................10 3.1.14 Alarms and Warnings.................................................................................11 3.2 DATA.....................................................................................................................11 3.2.1 Data – Batch Reports.................................................................................11 3.2.2 Data Collection - SCADA..........................................................................11 3.2.3 ER / ES Requirements (FDA CFR 21 Part 11)..........................................11 3.2.4 Display requirements.................................................................................11 3.3 INTERFACES...........................................................................................................12 3.3.1 User Interface............................................................................................12 3.3.2 Interface with Supervisory Systems...........................................................13 3.3.3 Interface with Peer Equipment..................................................................13 3.3.4 Interface with Equipment..........................................................................13 3.4 ENVIRONMENT......................................................................................................14 3.4.1 Layout........................................................................................................14 3.4.2 Physical Conditions...................................................................................14 3.4.3 Intended Operating Environment:.............................................................15

4

CONSTRAINTS..............................................................................................................16 4.1 MILESTONE SCHEDULE REQUIREMENTS...............................................................16 4.2 EQUIPMENT CONSTRAINTS...................................................................................17 4.2.1 Environmental Conditions.........................................................................17 4.2.2 HVAC Equipment Constraints...................................................................17 4.2.3 Equipment Generated Vibration................................................................18 4.3 COMPATIBILITY WITH PLANT CONTROL SYSTEM.................................................18

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USER REQUIREMENTS SPECIFICATION

Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

4.4 COMPATIBILITY WITH STANDARD COMPONENTS..................................................18 4.5 CONSTRUCTION COMPATIBILITY...........................................................................19 4.6 BUILDING COMPATIBILITY....................................................................................19 4.7 COMPATIBILITY WITH PLANT UTILITIES...............................................................19 4.8 AVAILABILITY.......................................................................................................20 4.9 PROCEDURAL CONSTRAINTS.................................................................................20 4.10 MAINTENANCE REQUIREMENTS............................................................................21 5

LIFE CYCLE.................................................................................................................22 5.1 DEVELOPMENT PROCEDURES................................................................................22 5.2 TESTING REQUIREMENTS......................................................................................22 5.3 DELIVERY REQUIREMENTS...................................................................................22 5.3.1 Delivery of System.....................................................................................22 5.3.2 Delivery of Documents..............................................................................23 5.4 SUPPORT................................................................................................................24 5.4.1 Start-up Support (list available options)...................................................24 5.4.2 Post Start-up Support (list post-startup support available)......................24

6

GLOSSARY...................................................................................................................26

7

REFERENCE DOCUMENTS............................................................................................27

8

APPROVALS..................................................................................................................28

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USER REQUIREMENTS SPECIFICATION

Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

NOTES for use of the User Requirements Template: Upon completion of the template, delete this page prior to updating the Table of Contents and printing. 1. This document contains italic text that is intended to provide guidance and examples on what should be included in each section. 2. Many areas of this template have selections or tables that have been prepared for guidance and ease of template completion. Any options and/or examples that are not applicable to the specific document being created should be deleted as well. 3. To update the final Table of Contents, place the cursor inside the shaded area, press the Right mouse key, and select Update Field. 4. Where possible, the User should identify the source (e.g. studies, standards, etc.) for the acceptable ranges of variables or other critical requirements that have been derived.

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USER REQUIREMENTS SPECIFICATION

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Doc ID: Glassware Washer URS_0 April 17, 2003

REVISION HISTORY Rev

Date

Author

0

17 – Apr - 03

BEF

Revision Summary Initial Release

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Project # Insert the unique project number associated with this particular URS Document # Insert the Document ID and Revision Document Description Insert Document Description, i.e. Laboratory Glassware Washer User Requirements Specification

1 INTRODUCTION Describe who produced the document, under what authority, and for what purpose Example This document has been produced by the Project Engineering Department of XYZ Engineering under authority of ABC Pharmaceuticals. The purpose of this document is to define the customer’s requirements for the purchase and construction of a glassware washer and its associated automated control system. Describe the contractual status of the document. Include, or reference as an attachment, the “legal” paragraph that communicates the customer’s purchasing terms and conditions in this section. Example This document is a legal and binding document between ABC Pharmaceuticals and the Supplier. 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. Include validation plans, other equipment specifications (such as engineering company specifications), data sheets, etc. State the relationship to other specifications that may be provided. Should the URS supercede statements made in other specifications that could have been provided by engineering firms and may be out of date. Note that the Equipment Validation Plan outlining the Supplier’s responsibilities is attached.

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Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

2 OVERVIEW State why the washer is being purchased - expansion, modernization, new construction, increased reliability, washing of specific machine parts (ie. Slats). Example The glassware washer shall clean and dry the glassware and /or other items listed below. The washer is being purchased to increase the amount of glassware that can be clean in a workweek. Expansion of our XYZ product facility has increase the amount of used glassware produced requiring an acceleration of the cleaning process. State the key objective and benefits of the new washer Example The washer shall allow unattended washing and drying of the items. This will allow the cleaning personnel time to prepare the next batch to be washed, increasing throughput. The process of washing shall also become more consistent and reliable, as it will not be based on human activities alone. State the main functions and interfaces of the new washer Example The washer shall be capable of being operated by standard washroom personnel. The washer shall be tied into the Building Automation System (BAS) as well as the plant’s SCADA system.

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Doc ID: Glassware Washer URS_0 April 17, 2003

3 OPERATIONAL REQUIREMENTS Describe in detail the operational requirements of the system including system functions, interfaces and data. Define the environment in which the system must operate. Critical features must be identified. 3.1

Functions 3.1.1

Items to be cleaned The washer shall be designed to clean the items listed in Table A. Items may be placed on any number of racks. If possible, items shall be grouped per load as shown. Samples of items to be cleaned will be provided for use by the vendor to design the washer and associated equipment. If samples are not available, drawings of the items will be provided.

3.1.2

Soil Load The items to be cleaned will be soiled with the materials listed in Table A. The amount of soil ranges from ______________. Soiled samples of all items to be cleaned will be provided for the FAT. As an alternative to the product, the items to be cleaned at the FAT may be soiled with _________________.

3.1.3

Cleaning Compounds Based on the soil loads listed, the following cleaning agents have been initially selected for use.

3.1.4

3.1.3.1

XXX Cleaning Solution

3.1.3.2

YYY Acid Solution

Cleaning Cycle The following cycle shall be used as a starting point for the cleaning process. 3.1.4.1

Prewash

3.1.4.2

Detergent Wash

3.1.4.3

Rinse

3.1.4.4

Rinse

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Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

3.1.5

3.1.4.5

Purified Rinse

3.1.4.6

Dry

3.1.4.7

Cool Down

Throughput The existing system for washing these items has a throughput of XXX items per day. The washer shall be designed to satisfactorily clean and dry the amounts of items listed in table A. Table A

Item To Be Washed 4 Liter Carboys

Qty / Day

Dwg Attached

Soil Load

10

Yes

Dry Powder

Comments It is preferable to wash 4 at a time.

3.1.6

Definition of Satisfactorily Clean Satisfactorily clean is defined by the following criteria – State the criteria for an item to be clean (i.e. swab testing with X results, no visible product, TOC levels, rinse conductivity levels)

3.1.7

Definition of Satisfactorily Dry Satisfactorily dry is defined by the following criteria – State the criteria for an item to be dry (i.e. dry to the touch, no large water droplets, 100%)

3.1.8

Modes of Operation The washer shall only allow automatic operation. The operation shall be started only after the user has loaded the items to be washed, selected the predetermined wash cycle for the load and pressed the Start button.

3.1.9

Performance The washer shall have an efficiency rate of XXX%, as measured by the actual number of items cleaned during a test day, divided by the number of items specified to be washed per day. Washer efficiency rate excludes downtime due to faulty commodities or supply issues but includes downtime due to maintenance of the washer.

3.1.10 Cycle Time The maximum time desired to run one complete wash / dry cycle is XXXX. 3.1.11 Power Failure / Recovery List any specific requirements for power failure recovery

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Insert your specific power failure/recovery scheme here. For example: Upon failure of the 3-phase power supply, the washer shall fail to a safe state. Operation shall not restart upon power restoration. Operator intervention is required to restart a cycle. The control system shall maintain its program after a power loss and it shall be able to recover with minimal interaction with the operator. “Safe State” is defined by the following attributes:  Supply valves will fail closed  All motion shall cease  Motion shall not be resumed without operator interaction  Cleaning cycle status shall be reset 3.1.12 Emergency Stops List any unique requirements relating to safely shutting down the system, including interactions with other systems For example: Emergency-stop buttons shall be supplied within the reach of the operator at normal operator stations. When activated, the emergency stop shall shut the system down immediately in accordance with the following requirements:    

Supply valves will fail closed All motion shall cease Motion shall not be resumed without operator interaction Cleaning cycle status shall be reset

3.1.13 Safety – Operator Consider performing or having the supplier perform a risk analysis. For example: The washer shall be designed to be as safe as possible. Interlocks shall be provided on the doors to prevent operation with a door opened. The control panels shall be lockable to prevent unauthorized access.

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Glassware Washer

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Additional safety features shall be considered for other operator hazards. 3.1.14 Alarms and Warnings A list of alarms that are a must be included here. For example: The washer shall monitor its components and have alarms based on component or supply failure. These alarms shall alert the user to possible damage that may occur in the future if proper maintenance is not performed. Alarms shall also be added to protect the process. If the process deviates from the validated cycle, the user must be alerted. 3.2

Data This section should consider the data collection, data storage, and critical parameters. Reference to SCADA systems. Data requirements for printed reports. 3.2.1

Data – Batch Reports List critical parameters and useful information to be included on the report. Batch reports shall include the following data. All items to be input by the operator are marked with an asterisk.

3.2.2

Data Collection - SCADA List critical parameters to be transmitted to the SCADA system. The following information will be collected via the building SCADA system.

3.2.3

ER / ES Requirements (FDA CFR 21 Part 11) List any specific requirements for the storage / collection of data applicable to CFR 21 Part 11.

3.2.4

Display requirements List any special requirements for data to be displayed on the OIT. Examples include P&ID, reports, date / time formats.

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Glassware Washer

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3.3

Interfaces The Programmable Logic Controller / Operator-Interface system (hereafter referred to as the “control system”) shall include interfaces with the Operators, Maintenance personnel, Supervisory personnel, external equipment, and the User’s building control system to ensure safe, reliable, continuous, and automatic operation and easy, safe, secure and reliable configuration. This section deals with the interfaces to the washer. Sections should deal with: -user security requirements -user titles and functions -interaction with other systems -interaction / setup of equipment 3.3.1

User Interface The OIT shall incorporate a system for user identification and security as specified in CFR 21 Part 11. Each user who logs onto the system shall be clearly identified by their User ID.

Operator

Maintenance

Supervisor

Administrator

User access levels shall be defined below. The maximum number of each category is listed in the table. Functions available to each user level are marked with an X in the table.

Maximum # of users

10

5

5

1

Start automatic operation

X

X

X

Stop automatic operation

X

X

X

Manually trigger I/O

X

X

Access I/O configuration screens

X

X

Attribute / Functions

Define recipes / cycle data

X

Define users / user levels / passwords

Add columns and rows as necessary Add requirements for security (formats, number of independent users, category types)

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X

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Glassware Washer

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3.3.2

Interface with Supervisory Systems Describe in detail the interaction the system has with Supervisory Systems. These systems include BAS, SCADA, MRP, etc. Details must include data to be transferred, transfer mechanism, data defaults, and configuration details. Reference any additional specifications to be included with this document. Example The washer system must integrate with the customer’s Building Automation System. The BAS shall indicate the following building conditions: Fire Alarm, Loss of HVAC, Drain Neutralization System Status. These conditions shall be transmitted to the washer via dry contacts on the BAS PLC. Connection to these contacts shall be by the customer.

3.3.3

Interface with Peer Equipment Describe in detail the interaction the system has with any peer equipment. These systems include loaders / unloaders, conveyor lines, purified water systems, etc. Details must include handshaking data, transfer mechanism, data defaults, and configuration details. Reference any additional specifications to be included with this document. Example The washer system must communicate with the USP System PLC. The washer system shall indicate its request by sending a data signal via Data Highway Plus to the USP system. The USP system shall respond to the request by granting the USP token and opening the point-of-use valve. More details are shown in the USP System Communication Specification 1.

3.3.4

Interface with Equipment The control system shall include interfaces with external equipment to ensure safe, continuous, and automatic operation. Describe the I/O system that shall be used. If required, specify the control voltage (24VDC, 120VAC, etc). Detail any device level networks to be used (DeviceNet, Profibus, ControlNet). Example The control voltage shall be 24VDC. Analog devices shall be 4 – 20mA. Where possible, inputs and outputs shall be DeviceNet style. A DeviceNet scanner card shall be located in the PLC’s local rack.

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3.4

Environment Provide details of the physical environment in which the [equipment/system] will be operated. 3.4.1

Layout For example: 1. Allocated floor space for the equipment is _____ inches by ________ inches with at least a _______inch corridor around the periphery for the equipment. 2. Vertical clearance is _________ inches. 3. Floor Loading is

pounds/ft2

4. See attached drawing #________________________ (if applicable). Layout is specific to the size equipment being used and system requirements of the equipment. 3.4.2

Physical Conditions  Room Explosion Classification List the critical explosion requirements for the room. 

Room will be non-hazardous

 Room will be Class I Div II (Zone 2) (explosive atmosphere present at known times)  Room will be Class I Div I (Zone 1) (explosive atmosphere present at all times) 

Environmental Classification List the critical air quality requirements for the environment. 

Class 100, 10,000, or 100,000 (Federal Standard 209E)



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

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

Directional airflow

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



Airflow velocity



Number of air changes



Particle Ingress

Rating of enclosures List the rating requirements for enclosures in the environment.

3.4.3



NEMA 1 (Open)



NEMA 12 (Oil tight)



NEMA 4 (Wash down)



NEMA 4X (Wash down and non-Corrosive)

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 GMP environment with a temperature range of 15 to 25 °C, non-condensing humidity. Vibration levels in operating environment are The Seismic Zone in the operating environment is .

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4 CONSTRAINTS 4.1

Milestone Schedule Requirements 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. A more extensive timeline should be included in the Quality and Project Plan. The Supplier shall provide a written proposal within X weeks of receipt of this document at the Supplier’s local office. The Supplier shall provide a Functional Specification within X weeks of receipt of the purchase order. The User shall review, comment and/or approve, and return the Functional Specification to the Supplier within X weeks of receipt from the Supplier. The Supplier shall provide the Factory Acceptance Test Specification within X weeks prior to the scheduled date of the FAT. The User shall review, comment and/or approve, and return the test specifications to the Supplier within X weeks of receipt from the Supplier. The washer shall be delivered to the User’s receiving dock on or before XX / XX / XXXX. OR Written proposal / quote required date Purchase order will be placed by: Functional Specification delivery date: Factory Acceptance Test delivery date: Factory Acceptance Test approval date: Equipment is required on-site by:

OR

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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

HVAC Equipment Constraints Process air enters in from… C

Indoor Temperature: Outdoor Temperature: Minimum:

C

Maximum:

C

Climatic conditions:

4.2.3

Winter dry bulb

C

Winter wet bulb

C

Summer dry bulb

C

Summer wet bulb

C

Equipment Generated Vibration The maximum allowable equipment vibration generated during operation is .

4.3

Compatibility with Plant Control System 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.

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The Supplier shall use a Manufacturer Model # Programmable Logic Controllers to control the washer system. A Type communication port shall be supplied for programming. The Supplier shall provide documentation that the application program was developed and coded using Manufacturer Program Name development and documentation software. The Supplier shall adhere to the following format for all instrument tags on the washer. Detail the format. The Supplier shall include the following information on all documents and drawings for the project. Detail the information. 4.4

Compatibility with Standard Components Include any requirements for preferred manufacturers. Include any special provisions for components not normally used in this type of application (example – heavy duty triclamps) The Supplier shall use reliable, commonly available, non-proprietary components that have been proven to be suitable for the intended service. If the User has any preferred components to minimize the User’s spare parts inventory, these items shall specified to the Supplier in the form of a User’s Preferred Vendor List. The Supplier shall make all possible attempts to use the User’s Preferred Vendor List3. Any deviations from the PVL should be first approved by the User.

4.5

Construction Compatibility All product contact parts shall be constructed from materials acceptable to the product and sterility assurance methods. Certificates for material, weld and finish shall be provided. Include any requirements for surface finish, diaphragm types, metal. Example All wetted surfaces shall be constructed of T316L stainless steel with a 15 Ra finish. Welds shall be continuous, and ground and polished to match the material surface finish. Process water piping shall be constructed of T316L stainless steel with a 15 Ra finish on the interior. Purified water piping shall be constructed of T316L stainless steel with a 15 Ra finish, electropolished on the interior.

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Teflon gaskets must be used. Exterior non-wetted surfaces shall be constructed of type 304 stainless steel with a #4 finish. Welds shall have color removed. 4.6

Building Compatibility To be able to be moved into the building, the Supplier must disassemble the washer so that its individual parts with a maximum length of X” long can fit through a X” wide by X” high door. Specify means by which washer will be reassembled, ie bolted and gasketed or welded.

4.7

Compatibility with Plant Utilities The User shall ensure that the following utilities are available and that the utility supply lines and piping are terminated with fittings or connections that are compatible with those listed below. The Supplier shall specify utility data, which is marked with an asterisk (“*”). Utility requirements, which are not specified or marked with an asterisk, shall be brought to the attention of the User. These requirements shall be approved by both the User and the Supplier before system design begins. Electrical – 3 / 60 Hz / 480 VAC 30 Amps Purified Water – USP 25 GPM @ 40 PSI @ 80C Potable Water – House 50 GPM @ 30 PSI @ 40C Steam – 60 PSI, Load * Compressed Air – Instrument Quality, 25 CFM @ 90 PSI Drain – 3”, 40 GPM maximum Exhaust – 12” Duct, ½” Static Pressure Drop

4.8

Availability The washer is intended to be operated X days per week, X hours per day. The maximum down time permitted for maintenance is X hours per day.

4.9

Procedural Constraints Describe any local procedural requirements such as local standards that must be adhered to. Attach a copy of those standards if possible. The washer shall be designed to meet cGMP 21 CFR part 210 and 211 as published at the time of order.

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Controls for the washer shall meet the NFPA/NEC 70 and 79 for industrial machinery. Control panels for the washer shall meet the Underwriters Laboratories UL-508A certification for industrial equipment. The washer shall meet all applicable OSHA regulations for the safety of operators of equipment with regards to safety, guarding and noise. The washer shall meet CE requirements if delivered to the European Community. All piping welds shall meet ASME and 3A specification requirements. Other standards are attached. The Supplier shall adhere to the indicated sections only. Installation, operation, and maintenance instruction documentation for the system shall be design to be comprehendible by a high school graduate. 4.10

Maintenance Requirements 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. Include the term of the standard support.

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5 LIFE CYCLE 5.1

Development Procedures The project shall use the GAMP methodology when developing the system and documentation. Per GAMP, the Supplier shall provide a Quality and Project Plan as part of its proposal. The Supplier shall have a quality system in place. Internal quality procedures shall be available for the User’s review. The Supplier shall provide a Project Manager for the project to provide a single communication point with the User. Reference here any internal development procedures necessary. Show them as attachments or references.

5.2

Testing Requirements 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 machine performance, the User shall witness the execution of the approved Factory Acceptance Test procedures. The Supplier shall notify the User X weeks in advance of the start of this test. The User shall supply a sample of the items to be cleaned X weeks in advance of the start of this test. User shall supply material to be used to soil samples. User shall supply cleaning chemicals in sufficient quantities for testing.

5.3

Delivery Requirements 5.3.1

Delivery of System The washer, with all options, equipment, and the documentation listed below, shall be delivered to the User’s receiving dock by the date listed above. Each crate shall be labeled with the equipment model and serial number, Supplier’s name, project number and purchase order number.

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5.3.2

Delivery of Documents 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:



Project Plan

Microsoft Word XX (*.doc)



User Requirements Specification

Microsoft Word XX (*.doc)



Functional Specification/Requirement

Microsoft Word XX (*.doc)



Design Specifications

Microsoft Word XX (*.doc)



Controls Test

Microsoft Word XX (*.doc)



Hardware Installation Test

Microsoft Word XX (*.doc)



Operational Test

Microsoft Word XX (*.doc)



Factory Acceptance Test

Microsoft Word XX (*.doc)



Operator, Maintenance and Service Manuals

Microsoft Word XX (*.doc)



Process and Instrumentation Diagram (P&ID)

AutoCAD version XX.X (*.dxf)



Instrument Listing

Microsoft Word XX (*.doc) or Excel XX (*.xls)



Control Schematics

AutoCAD version XX.X (*.dxf)



Control Panel Assembly Drawings

AutoCAD version XX.X (*.dxf)



Equipment Assembly Drawings

AutoCAD version XX.X (*.dxf)



Bill of Materials

Microsoft Word XX (*.doc) or Excel XX (*.xls)



Spare Parts List

Microsoft Word XX (*.doc) or Excel XX (*.xls)

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

Component Cut Sheets

Microsoft Word XX (*.doc) or Excel XX (*.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. 5.4.1

Start-up Support (list available options) 5.4.1.1

5.4.2

Training (list training options available)

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)

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Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

6 GLOSSARY If necessary, attach a glossary that includes definitions of terms that may be unfamiliar to the Supplier or terminology which have meanings specific to entries on this User Requirements Template GMP / cGMP

Good Manufacturing Practices. Regulations of the FDA and comparable non-US agencies that describe the minimum standards for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding of a drug to assure that such drugs meet the requirements of the Act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

PLC

Programmable logic controller

OIT

Operator interface terminal

GAMP

Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life-cycle model. Specifically designed to aid suppliers and user in the pharmaceutical industry.

CFR 21 Part 11

Part of the FDA Code of Federal Regulation. Part 11 deals with Electronic Records and Electronic Signatures. Specific requirements are laid out for the production, storage, and editing of electronic records.

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USER REQUIREMENTS SPECIFICATION

Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

7 REFERENCE DOCUMENTS List is a list of all documents referenced in the URS. Include all additional specifications from engineering companies, validation plans, drawings, etc. Be aware that documents not listed here may be lost and not referenced in the corresponding specifications from the Supplier. List references that were used in preparing this document or provide additional details. Examples are User’s project schedule, the GAMP guide, etc.

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Glassware Washer

Doc ID: Glassware Washer URS_0 April 17, 2003

8 APPROVALS Insert your company’s standard approval page at the appropriate position in the document or use 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. Reviewed and Approved by _________________________________ User Project Manager

__________ Date

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

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__________ Date