In pharmaceutical industry, user requirement specification (URS) play a vital rule to select an appropriate equipment or machine containing a list of all the requirements. After the preparation of URS, the document is sent to the manufacturer to get the required equipment or machine as per the given criteria.


Content of URS

A typical URS contain the following list of contents, which may slightly increase or decrease depending on the type of machine/ equipment.

1. Introduction

2. Objective

3. Operational Requirements

  • Functions
  • Interface
  • Environment
  • Constraints

4. Life Cycle Requirements 

  • Design Review
  • Commissioning Requirements
  • Document Requirements
  • Qualification Requirements
  • Life Cycle Testing
  • Maintenance
  • Training

5. Other Requirements as Appropriate

  • Type of Construction
  • Materials to be Used
  • Cleaning
  • Effectiveness of Seals
  • Heat Insulation
  • Electrical Requirements
  • Noise

6. Delivery

7. Traceability

8. Factory Acceptance Test (FAT) / Site Acceptance Test (SAT)

9. Export Packaging, Delivery FOB, Insurance and Protection

10. Reference Documents

11. Abbreviations and Definitions

12. Change History


So, the SOP of URS should be contain above mentioned information to prepare a user friendly URS.


User Requirement Specification Example

  • User Requirement Specification for Balance
  • User Requirement Specification for HPLC
  • User Requirement Specification for Compression Machine


FAQS

1. What is the difference between URS and FDS?

Usually User Requirement Specification (URS), provided by the customer, where the Functional Design Specifications (FDS) explain how the system operate. 


2. Wha is the difference between URS and SRS?

URS (User Requirement Specification) contain- as a user what do you expect from the system. Where SRS (System Requirment Specfication) contain- to met the URS, how to design the system. What system


Related: Validation, Calibration and Qualification in Pharmaceutical Industry


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