Services for the Life Sciences

Temperature Mapping

Software Validation

Biometrix has extensive experience in the development and execution of high quality software validation protocols. Biometrix can provide and execute software validation protocols such as Installation, Operational and Performance Qualification. Biometrix can also develop software specification documents such as Design, Functional and User Requirement Specifications.

Biometrix can provide expert software and computer related systems validation consulting services for a variety of systems, including:

  • Calibration management
  • Laboratory monitoring
  • Quality management
  • Document control 
  • Pipette calibration
  • Clinical trials management
  • Capital equipment management
  • PLC-based systems
  • Microprocessor-based systems
  • Software-based control systems, including DeltaV 

Biometrix provides a comprehensive validation report package that includes a summary of all test results including deviations, the executed protocol, test data, test equipment calibration data with NIST-traceable calibration certificates. The validation report package is carefully prepared, reviewed and submitted for client approval.


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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
  • 162 Common Lane, PO Box 21
  • Prides Crossing, MA 01965-0021
  • Tel: (978) 338-5263