User requirements specification (URS) is a document that defines user's requirements and expectations with regard to a final product.
A final product means individual units of equipment and system associated with it, as well as software that can be installed on this system.
The URS relates not only to regulatory requirements, such as Good manufacturing practices, but it is also necessary for subsequent equipment/systems qualification activities.
However, considering it as an integrated document which unites various requirements and contributes to achievement of planned design objectives is more correct.
All existing equipment/system requirements must be included in the URS.
The URS is usually compiled by a consumer, sometimes - by an equipment/system supplier or by a third party - advisory organization.The URS for pharmaceutical equipment/system contains:
- Introduction
- brief description of the document objective and purpose;
- determination of user's primary needs;
- determination of the design scope, etc.
- Requirements (functional, operational, additional ones)
- description of critical requirements;
- description of highly desirable and desirable requirements;
- conditions in which equipment/systems should be operated, etc.;
- description of processes and schemes as needed.
- References
- Abbreviations and definitions (explanations of specific terms);
- List of the documents used to prepare this document;
- Any other general comments relating to this URS.
The URS and equipment/system supplier specification is the basis for the equipment and/or system testing during acceptance and qualification, when it is documented that the proposed equipment/system is suitable for its intended use and meets GMP requirements.