User Requirement Specifications (URS) in Pharmaceuticals

What is User Requirement Specifications (URS)?

Definition of User Requirement Specifications (URS): These are a set of documented requirements that describe the features, functions, and characteristics of a system or product from the perspective of the end-user. These specifications serve as a foundation for designing and developing products that meet the needs and expectations of users.

User Requirement Specifications (URS) in Pharmaceuticals

Procedure for preparation of the URS:

  1. User Department is responsible for creation of the URS.
  2. Upon identification of requirement whether it is software, Equipment or any user requirement ideally should be driven through the URS process.
  3. User department will identify the minimum requirement or user requirements and short list the vendor of particular software or Equipment.
  4. User Department shall inform the Quality Assurance department to allocation the URS No.
  5. User Department will write the written document in the as per SOP format and URS shall be reviewed by Department followed by the higher Authority (Head) for approval of the URS.
  6. Approved URS shall be send to the vendor for final acceptance of the URS.
  7. Vend or Verifier shall accept the URS requirement and communicate same with the URS acceptance.
  8. URS contain the below requirement but not to limited,

User Requirement Specification or URS Contains:

  1. Introduction of Product/Equipment/Software
  2. Objective
  3. Purpose
  4. Definition
  5. Minimum Configuration (That may include technical requirements, functional requirements)
  6. Operational Requirements (That may include Functionality, Environmental condition, Interfaces, Constraints, Capacity)
  7. Life Cycle requirements (That may include Life cycle testing, Documentation, Qualification Requirements, Maintenance)
  8. Material specifications
  9. DQ/IQ/OQ/PQ Requirements
  10. 21CFR11 Justification, cGLP or cGDP followence and Other regulatory configuration
  11. E-signature and Backup configuration as per current standards.
  12. Training and User Support by Vendor
  13. Safety Requirements
  14. Supports and Services Agreements
  15. Manual or Specification Documents
  16. Delivery
  17. Traceability of Standards
  18. Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT)
  19. Reference Documents
  20. Delivery, Tentative Packaging, Insurance and Protection
  21. Abbreviation & Attachments
  22. Change History

A. FORMAT OF USER REQUIREMENT SPECIFICATION (URS)                                    

<Company Name & Logo>   


Product NameMake/Model
URS No.Page No.X of Y

URS Contain:


Prepared By/Date (User Department)Reviewed By/Date (HOD)Reviewed By/Date (QA)Approved By/Date (Head)
<SOP Format No.>


<Company Name & logo>

Log for URS No.

Sr. No.TitleRequesting DepartmentURS No.Assigned By/DateRemarks  (If any)

Frequently Asked Questions  

Que 1: Are User Requirements Specifications (URS) permanently required for validation?  

  • Ans: User Requirements Specifications are a useful tool for making sure a system will accomplish the tasks users require of it when it is being developed. User requirements are the functional equivalent of the Functional Requirements in Retrospective Validation, where an existing system is being validated.
  • Other Document Names and Abbreviations Occasionally, the following expressions or abbreviations are used: User Requirements Specification, User Requirements, User Specifications, URS, UR, and US.

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