BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


AABB Consulting

AABB Accreditation is an important step for any Blood Bank or Cellular Therapy facility.  The AABB now requires full GMP validation and calibration compliance.  Ensuring that all laboratory systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.  Let Biometrix help your facility with your validation and calibration needs.  Biometrix provides the following services to assist with the AABB Accreditation process:

  • Calibration and NIST traceable certification of laboratory equipment
  • Validation of laboratory equipment
  • Annual or otherwise specified re-validation of equipment
  • Development of Validation and Calibration Master Plans

 

 



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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