User Requirements Specifications (URS) are prepared for each critical utility or piece of equipment prior to the manufacturing stage. The specification provides a list of requirements for the planned system. The User Requirements Specification specifies the needs of the end user as well as any regulatory requirements. The document is provided to the supplier in order to ensure that all expected requirements, of the end user, for the utility or piece of equipment have been specified and supplied prior to the actual manufacturing stage. These specifications will be the basis for the Functional Requirements Specification and the Hardware and Software Specifications that detail the design of the utility or piece of equipment.

Why produce a URS?

User Requirements Specifications are required to protect both the end user and the manufacturer. All Requirements of the end user will be supplied in the URS prior to the manufacturing of the utility or piece of equipment. This enables the manufacturer to produce the product to the end user’s expectations. The manufacturer has the opportunity to review the URS and incorporate the requirements in their system or offer alternatives to meet the requirement. Some requirements may not be possible to supply and therefore will be addressed prior to the manufacturing stage eliminating possible problems before they occur. The User Requirements Specification document may evolve with the project and is provided with a Revision History section in order to document any changes that occur throughout the project stages. The final version of the URS will be a controlled document that can be referenced should any questions arise regarding the final product. The manufacturer must ensure that all aspects of the URS have been understood and that all requirements can be fulfilled, or alternatives offered, in order to meet the end user’s expectations.

What does a URS contain?

The User Requirements Specifications include (but are not limited to) the following common sections:

Identification of Writer, Approvers:

Provides documented evidence on the personnel involved in preparing and approving the document.

Revision History:

A revision history is maintained to record any changes to the document and the date they occurred.

Introduction:

Defines the purpose and scope of the User Requirement Specification with respect to the design of the utility or piece of equipment.

Overview:

Gives a background and objective of the utility or piece of equipment that is being considered with an overview of its functions.

Operational Requirements:

Will list the requirements for the function of the system which include, but are not necessarily limited to, Sequence of Operation, Cycle of Operation, and Machine Performance.

Control System Requirements:

Will list the requirements for the control system which include, but are not necessarily limited to, Functions, Safety, User Interfaces, Electronic Records and Signatures, Security, Alarms, and Utilities.

Hardware and Software Requirements:

Will list the specific requirements for the control system which include, but are not necessarily limited to, Interferences, Environment, Hardware, Operating System, and Application Software.

Glossary:

Definition of all the terms that have been referenced in the document.