The Functional Specification is a specification document that describes the detailed functions of the equipment or system, specifically what the equipment or system will do. The Functional Specification is linked to the Operational Qualification which tests all the specified functions.

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

• reduced cost and time to achieve a compliant system
• improved compliance with the regulations by using a common and comprehensive validation approach
• elimination of the need for time-consuming retrospective validation
• clarification of the division of responsibility between user and equipment or system supplier

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