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.
