Document Number: _______
Document Title:
USER REQUIREMENTS SPECIFICATION – URS for Version:
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USER REQUIREMENTS SPECIFICATION – URS for
_______________________________
Project No.: _____________
TECHNICAL CONTENT
Prepared by: Job title Signature Date
SME (SUBJECT MATTER EXPERT)
Reviewed by: Job title Signature Date
QUALITY ASSURANCE
Approved by: Job title Signature Date
Document Number: _______
Document Title:
USER REQUIREMENTS SPECIFICATION – URS for Version:
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Table of Contents
1. Introduction ......................................................................................................................................................... 4
1.1 Purpose of Document: ..................................................................................................................................... 4
1.2 Scope: .............................................................................................................................................................. 4
2. Regulatory Compliance ...................................................................................................................................... 4
2.1 Regulatory Standards: ..................................................................................................................................... 4
3. User Requirements ............................................................................................................................................. 4
3.1 Functional Requirements: ................................................................................................................................ 4
3.2 Performance Requirements: ............................................................................................................................ 4
4. Environmental and Operational Conditions ..................................................................................................... 4
4.1 Environmental Requirements: ......................................................................................................................... 4
5. Technical Specifications .................................................................................................................................... 4
5.1 Material of Construction: .................................................................................................................................. 4
5.2 Dimensions and Space Requirements: ........................................................................................................... 4
5.3 Utility Requirements:........................................................................................................................................ 4
6. Criticality and Risk Assessment ........................................................................................................................ 4
6.1. Criticality ......................................................................................................................................................... 4
6.2. Risk Assessment ............................................................................................................................................ 4
6.3. Testing Requirements..................................................................................................................................... 4
7. Safety and Ergonomic Features ........................................................................................................................ 5
7.1 Safety Features: .............................................................................................................................................. 5
8. Quality and Compliance Features ..................................................................................................................... 5
8.1 Validation Requirements: ................................................................................................................................ 5
8.2 Calibration and Maintenance: .......................................................................................................................... 5
8.3 Documentation Requirements: ........................................................................................................................ 5
9. Data Integrity and Control .................................................................................................................................. 5
9.1 Data Requirements: ......................................................................................................................................... 5
10. Supplier and Vendor Requirements ................................................................................................................ 5
10.1 Supplier Qualification: .................................................................................................................................... 5
10.2 Post-Installation Support: .............................................................................................................................. 5
11. Budget and Cost Considerations .................................................................................................................... 5
11.1 Budget Overview: .......................................................................................................................................... 5
12. Delivery, Installation, and Commissioning ..................................................................................................... 5
12.1 Delivery and Installation ................................................................................................................................ 5
12.2 Commissioning: ............................................................................................................................................. 5
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USER REQUIREMENTS SPECIFICATION – URS for Version:
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13. Acceptance Criteria ........................................................................................................................................... 5
13.1 Acceptance Testing: ...................................................................................................................................... 5
14. Change Control and Revision Management ................................................................................................... 6
14.1 Change Management Process: ..................................................................................................................... 6
15. Appendices and Supporting Information ....................................................................................................... 6
15.1 Additional Information: ................................................................................................................................... 6
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USER REQUIREMENTS SPECIFICATION – URS for Version:
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REVISION HISTORY
Version that is changed Reason for change Version after the change Date of validity
Document Number: _______
Document Title:
USER REQUIREMENTS SPECIFICATION – URS for Version:
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1. Introduction
1.1 Purpose of Document:
Briefly describe the purpose of the URS and its significance in the procurement process.
1.2 Scope:
Define the scope of the equipment/system, including its intended use and the boundaries of the project.
2. Regulatory Compliance
2.1 Regulatory Standards:
List the regulatory standards and guidelines that the equipment must comply with (e.g., FDA, EMA, ISO).
3. User Requirements
3.1 Functional Requirements:
Detail what the equipment is expected to do, including operational parameters, capacity, and speed.
3.2 Performance Requirements:
Define the required performance levels, like efficiency, accuracy, and reliability.
4. Environmental and Operational Conditions
4.1 Environmental Requirements:
State the environmental conditions under which the equipment must operate.
5. Technical Specifications
5.1 Material of Construction:
Describe the materials required for the equipment.
5.2 Dimensions and Space Requirements:
Provide physical dimensions and space requirements.
5.3 Utility Requirements:
Outline the power, water, air, or other utility needs.
6. Criticality and Risk Assessment
6.1. Criticality
The criticality is performed in accordance to document _______. Include the parameter, the impact (direct,
indirect…) and justification for that.
6.2. Risk Assessment
Determine the risk method in accordance to Risk Management Procedure. Determine the risk priority for each
determined risk, having into consideration the likelihood of the risk, the severity of the risk and probability.
6.3. Testing Requirements
Based on the risks determined and their criticality, determine the testing requirements that should be performed.
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USER REQUIREMENTS SPECIFICATION – URS for Version:
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7. Safety and Ergonomic Features
7.1 Safety Features:
List necessary safety features and ergonomic considerations for operators.
8. Quality and Compliance Features
8.1 Validation Requirements:
Describe the necessary validation processes (IQ, OQ, PQ).
8.2 Calibration and Maintenance:
Specify calibration, preventive maintenance, and breakdown maintenance requirements.
8.3 Documentation Requirements:
Detail required documentation for operation and maintenance.
9. Data Integrity and Control
9.1 Data Requirements:
Address requirements for data integrity, electronic records, audit trails, and security features.
10. Supplier and Vendor Requirements
10.1 Supplier Qualification:
Criteria for selecting and qualifying equipment suppliers.
10.2 Post-Installation Support:
Expectations for training, technical support, and warranty.
11. Budget and Cost Considerations
11.1 Budget Overview:
Provide an overview of budget constraints and cost considerations.
12. Delivery, Installation, and Commissioning
12.1 Delivery and Installation:
Detail expected delivery timelines and installation procedures.
12.2 Commissioning:
Outline commissioning process and criteria.
13. Acceptance Criteria
13.1 Acceptance Testing:
Define criteria for accepting the equipment after installation and validation.
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USER REQUIREMENTS SPECIFICATION – URS for Version:
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14. Change Control and Revision Management
14.1 Change Management Process:
Outline the process for managing changes to the URS.
15. Appendices and Supporting Information
15.1 Additional Information:
Include any relevant diagrams, reference documents, and technical sheets.
Document Number: _______
Document Title:
USER REQUIREMENTS SPECIFICATION – URS for Version:
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Glossary
Glossary
Acronym Definition
C Degrees Celsius
CFR Code of Federal Regulations
cGMP common Good Manufacturing Practices
FAT Factory Acceptance Test
FDA Food and Drug Administration
GAMP Good Automation Manufacturing Practices
HEPA High Efficiency Particulate Array filter
EMA European Medicines Agency
Hp Horsepower
Hz Hertz
SAT Site Acceptance Test
SCADA Supervisory Control and Data Acquisition
URS User Requirement Specification
IQ Installation Qualification
OQ Operational Qualification
PQ Performance Qualification
SOP Standard Operating Procedure
WFI Water For Injection
