BioMetrix
Services for the Life Sciences



Validation
Calibration
Commissioning
Temperature Mapping


Performance Qualification

A Performance Qualification is a validation protocol that provides documented verification that equipment or a system is capable of performing or controlling the activities of a process according to written and pre-approved specifications while operating in its specified operating environment.

Performance Qualification testing and documentation typically includes verification of the Operator Training, SOP Approval and equipment or system process parameters. Process parameters are verified based on the specific equipment or system functionality and individual client process requirements.

Biometrix works closely with our clients to develop high quality Performance Qualification protocols. Our Performance Qualification protocols include a customized validation approach and methodology, clearly defined acceptance criteria and pre-determined expected results. We offer fast turnaround of documentation and can often schedule projects with short lead times.

Our validation personnel are always available to answer questions and can provide the kind of guidance that will assure a highly compliant protocol.

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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