BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping



Validation

Biometrix Corporation provides high-quality validation services to the pharmaceutical, biotechnology and medical device industries of North America. Our services and products include:

Document Development: Biometrix has extensive experience in the development of high quality validation documentation. Years of accumulated experience in the validation industry give Biometrix a competitive edge at being able to quickly develop validation documentation that meets the specific needs of our clients. Biometrix can provide our clients with high-level guidance documents such as a Validation Master Plan, and we can provide validation protocols such as Installation Qualifications, Operational Qualifications and Performance Qualifications.  We also provide specification documents such as Design Specifications, Functional Specifications and User Requirement Specifications.

Onsite Protocol Execution: Whether it’s executing a client protocol or executing a protocol that has been custom-developed by Biometrix, Biometrix Validation Engineers can provide quality on-site protocol execution services. Our Validation Engineers are trained in proper GMP documentation practices, deviation management and change control procedures. Additionally, they understand the importance of following our clients’ SOP’s. We follow written procedures documented in approved protocols and adhere to strict GMP documentation practices in order to provide an accurate and complete validation documentation package.

Autoclave Cycle Development
: Uncertain about how to configure your autoclave cycles and loads? Biometrix has extensive autoclave validation experience and can provide consulting services to assist our clients with the often difficult task of developing autoclave cycles and load configuration for validation. Biometrix can develop Cycle Development Protocols that meet our clients’ specific requirements and can provide the necessary on-site assistance in executing the protocol.

Validation Staffing: Biometrix can provide our clients with the right validation professional to help you manage your fluctuating validation requirements. Biometrix Validation Engineers can be used to augment your staff during shutdowns, for project work, facility built-outs or if an employee suddenly leaves the company.

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“We’ve used Biometrix to perform initial validation and re-validation of some of our most  critical equipment since 2003. Their protocols are thorough, yet not excessive. Their validation engineers are a pleasure to work with and are always available to answer questions and provide guidance. Working with Biometrix is a respite of smooth sailing – in an environment that is demanding and often changing.”

- Validation Manager for pharmaceutical company
















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