BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


User Requirement Specification

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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    Validation Services

    Validation Master Plan
    Autoclave Cycle Development
    Validation Staffing
    Validation Protocol
       Installation Qualification
       Operational Qualification
       Performance Qualification
    Specification Documents
       Design Specification
       Functional Specification
       User Requirement Specification
    Usability Studies
    AABB Consulting


    Equipment Qualification & Validation Capabilities

    Autoclave Validation
    Depyrogenation Oven Qualification and Validation
    Lyophilizer Validation
    Automated Filling Machine Validation
    Filling Machine Validation
    Freeze Dryer Validation
    Calibration Software Validation
    Centrifuge Validation
    Chromatography Box Validation
    Cold Room Validation
    Computer Systems Validation
    Environmental Chamber Validation
    Environmental Room Validation
    Filling Machine Validation
    Freezer Validation
    Glass Washer Validation
    Humidity Chamber Validation
    Incubator Validation
    Laboratory Monitoring System Validation
    Mixer Validation
    Oven Validation
    PLC Validation
    Refrigerator Validation
    Shaker Validation
    Software Validation
    Stability Chamber Validation
    Stir Plate Validation
    Stirrer Validation
    Warm Room Validation


    • Biometrix Corporation
    • 301 Edgewater Place, Suite 100
    • Wakefield, MA 01880
    • www.biometrix.com
    • Tel: (978) 338-5263