What is User Requirement Specification (URS)?

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URS provide the knowledge of basic user requirements to manufacturer / supplier about equipment / utility / facility proposed to be procured by the user.


The URS is then provided to the manufacturer/Supplier as an input for the quotation, design, construction, commissioning and validation of the system.


URS should clearly & precisely define what the user wants to the system to do. It should define the functions to be carried out, the data on which the system will operate.

The URS may also define any non-functional requirements, constraints. The emphasis of the URS should be on required functions & not on the methods of implementing those functions

•      Operational Requirements

•      Function Requirements

•      Technical Requirement

•      Environment Requirements

•      Regulatory Requirements

•      Safety Requirements

•      Documentation / Training


1.Operational Requirements include:

Operational requirements are those statements which identify the capabilities, requirements & performance measures to satisfies the needs of a person, group or organization.

Enable an organisation to produce a clear, considered and high level statement.

•      Available functions

•      Data flow

•      Interfaces

•      environment


2. Function Requirements:

Functional requirements are those which are related to the technical functionality of the system. Functional requirements specifies a function that a system or system component must be able to perform.

•      Safety

•      Security including access control

•      Audit trails

•      Use of electronic signatures

•      Output (e.g., reports. files)

•      Unambiguous error messages”

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3. Technical Requirement:

•      Basic Requirements: Specify the basic requirements form the manufacturer like basic layout of the equipment, installation Layout of the equipment, list of all components including material description, total weight and capacity.

•      Specific Requirement: Specify the other specific requirements related the specific equipment/utility/system.

•      Change over parts Requirement: Specify the required change parts if needed.

•      Any other specific requirements: Mention if applicable.


4. Environment Requirements

The environment in which the system is to work will be defined. The following will be addressed as appropriate:

•      Layout: The physical layout of the plant or other work place may have an impact on the system, such as long distance links or space limitations.

•      Physical Conditions: (e.g., temperature, humidity, external interference)

•      Physical Security:

•      Power Requirements: Voltage, amperage, filtering, Earthing protection, Uninterruptible Power Supply (UPS))

•      Any special physical or logical requirements    


5. Regulatory Requirements:  

•      21 CFR Part-11 compliance: Specify the regulatory requirement as applicable. When a new equipment/instrument is ordered need to comply as per IT manual and clearly specify IT related controls.

•      Data integrity: Specify the requirement of access control level for the data integrity.

•      Requirements of piping welds and product contact welds: Shall meet ASME and 3A specification requirements.

•      Inspection and testing: Specify the requirements of inspection and testing (FAT) at the supplier’s site before delivery.  


6. Safety Requirements:  

•      Requirements of Emergency stop, Alarms, and Indications and Interlocks: Shall available on the criticality of the equipment.

•      Desired personnel safety systems: Mention other safety requirements like electrical wiring must be concealed, Warning stickers on all hot surfaces, emergency stop function etc.

•      Power failure and recovery: Specify the requirement as needed.

•      Any other specific requirement: As required.


7. Documentation/Training:  

•      Desired Documents: Specify the required documentation support from the supplier.

•      Training: Specify the training requirements of technical staff.


Data handling requirements:

Consideration will be given to understanding the impact upon patient safety, product quality, and data integrity.

The following will be addressed as appropriate:

•      Definition of electronic records

•      Definition of data, including identification of characteristics, formatting, critical parameters, valid data ranges,

•      limits and accuracy, character sets, etc.

•      Required fields

•      Data migration

•      Data input and subsequent editing

•      Backup & Recovery

•      Archive requirements

•      Data security and integrity”


Guidelines for URS:

•      URS must only state the essential business needs from a user perspective, rather than various design aspect

•      Each requirement must be uniquely referenced to easy traceability

•      Requirement must not be repeated or contradicted

•      Each requirements must be testable & verifiable

•      The requirements should be defined at a high level as compared to the requirements defined in the FRS

Wherever possible, requirements should be prioritized. It should be to identify essential & desirable requirements.


 “Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


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https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

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