The User Requirement Specification is a document that defines what the equipment or system is supposed to do. It is normally written by the equipment or system users but can be written by other parties with input from the users. This document specifies all essential requirements (musts) and often includes a list of desirable requirements (wants) for the equipment or system. The User Requirement Specification is an important part of specifying equipment and systems and can be used as part of the vendor selection and purchasing processes. The User Requirement Specification is linked to the Performance Qualification, which tests the equipment or system in its normal operation environment.

The principal benefits that Biometrix can bring to our clients by writing a User Requirement Specification are:

• reduced cost and time to achieve a compliant system
• improved compliance with the regulations by using a common and comprehensive validation approach
• on-time, on-budget delivery of the validation project with the agreed quality standards
• clarification of the division of responsibility between user and equipment or system supplier

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