The user requirements specification (URS), is a formal document that defines the requirements for use of the equipment or software system in its intended production or functional environment. Generally, URS is required for new facilities, process equipment, laboratory equipment, computerized systems and utilities.
As per PICS Guide,
URS is a set of owner, user, and engineering requirements necessary and sufficient to create a feasible design meeting the intended purpose of the system
They (PICS) also added:
- The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.
- Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.
Related: SOP for User Requirement Specifications
As per ISPE,
The User Requirements Specification document contains requirements from multidisciplinary sources and supports design, commissioning and qualification activities, operations, and maintenance.
They (ISPE) also added:
- User requirements specifications are living documents that are updated as requirements change during any phase of a project or as additional risk controls are identified.
- 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, process 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.
Major Elements of URS
- Functional requirements
- Operational requirements
- Compliance requirements (Compliant with 21 CFR 11: Data integrity, Time and date, Electronic signature etc.)
- Support requirements
- Interfaces
Related: User Requirement Specifications Template
For computerized system, the URS should define critical data, data life-cycle controls that will assure consistent and reliable data throughout the processes by which data is created, processed, transmitted, reviewed, reported, retained and retrieved and eventually disposed.
General Guidance for URS Writing
- The focus should be on what is required, but not how it is to be achieved.
- The requirement statements should be actual, not be duplicated or contradicted.
- The document should be understandable for both the customer and the vendor.
- Requirements should be prioritized as mandatory or desirable.
- The URS should be modifiable but changes should be under a formal control procedure.
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