BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Warm Room Validation

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

All temperature data is collected using a GE Infrastructure Sensing Data Logger (Kaye Digi 2000) and premium quality thermocouples. All test equipment calibration is NIST traceable.

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.

Our Validation Engineers have experience with a vast array of Warm Rooms and can provide you with the high quality service that you demand. Our ultimate goal is to leave you with the peace of mind that your company’s validation requirements are being met.

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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