BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Functional Specification

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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    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