BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Validation Protocol

Validation is the process of providing documented evidence that equipment, systems and processes are installed, operate and perform as specified. The process of providing the necessary documented evidence is most commonly accomplished through the development of two different but complimentary groups of documents. These are specification documents and validation protocols.

Specification documents define how the equipment or system should be installed and operate, and how the equipment or system should perform during regular use in its normal operating environment.

Installation Qualification, Operational Qualification
and Performance Qualification protocols in turn, provide a series of tests and results that support the conclusion that the equipment or systems meet the requirements defined in the Design, Functional and User Requirement Specification. A robust validation protocol will contain an explanation of the validation approach and methodology, step by step test procedures and clearly defined, pre-approved acceptance criteria which traces directly to the specification documents, as well as clearly recorded supporting data.

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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