The User Requirements Specification document contains the requirements of user and supports design, commissioning and qualification activities, operations, and maintenance. It is written by the system owner and end-users early in the qualification and validation process.

 

Approval Page


Content Page


User Requirement Specification


  • Introduction: A brief discussion on purpose and scope of the document.
  • Operational requirements: Mention the functional requirements, operating system, capacity and specification.
  • Interfaces: Mention the user’s control system to ensure safe, reliable, continuous, automatic operation and easy, safe, reliable configuration.
  • Functional requirements: Mention the functional mode, capacity and specifications.
  • Tools: Mention the special tools required for maintenance of equipment.
  • Lifecycle requirements: Mention the design, commissioning and qualification requirements, documents requirements, maintenance and testing requirements. 
  • Other requirements: Mention the construction, cleaning, heat insulation, noise etc. (as appropriate).

 

User Requirements Example



As per ISPE recommendation,

Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are key inputs into user requirements specifications which are required to support the Quality Risk Management based Commissioning and Qualification process and are identified prior to User Requirement Specification generation.

Critical Design Elements (CDEs) are usually identified based on technical understanding of the products critical quality attributes, critical process parameters, and equipment/automaton design.

Critical aspects (CAs) are identified through system risk assessments. Critical aspects mitigate system risk to an acceptable level and are tested during commissioning and qualification. Critical design elements are identified during design development and implement critical aspects.

The user requirements specifications is living document and changes will be driven by changes in the requirements. FAT and SAT should not drive change, but you may discover a requirement that has been missed that needs to be added to the user requirements specifications through those activities. Any revision changes to the user requirements specifications will be addressed through change management.