Aabb Accreditation

Satisfying Validation and Calibration Requirements for AABB Accreditation

Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation 

AABB Accreditation now requires full cGMP calibration and validation compliance “Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP) regulations, CLIA ’88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality Management systems, competition within the blood banking profession, advances in the cellular therapy arena, and increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy communities conduct business. Conducting business in a quality framework is no longer an option, but a must. Ensuring that all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.”

-AABB website

Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation 

AABB requires that all accredited facilities validate their processes: AABB Standard: 5.0 Process Control The facility shall identify, design, and validate the policies, processes and procedures that affect the quality of cellular therapy products and services. Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation 

Specific cGMP requirements  

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Calibration plan Calibration files for each instrument, with instrument information forms and calibration certificates NIST-traceable Calibration of critical equipment Validation plan Validation of critical equipment

Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation Critical equipment for transfusion and cellular therapy laboratories        

Freezers Refrigerators Plasma Extractors Centrifuges Incubators Analyzers Rotators Syringe Pumps

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Water Baths Sealers Data Loggers Chart Recorders Biohazard Cabinets Balances Automated Core Blood Processors …and more

Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation 

Biometrix Validation Offerings for AABB Members 

Turnkey validation program set-up and operation 

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Validation master plan: A guidance document which outlines the overall validation approach and includes specific qualification activities and defines level of criticality and re-qualification schedule. Validation: Structured testing that provides evidence that all

equipment, systems and processes are consistently providing the desired level of quality. 

Re-validation: Defined schedule of re-qualification activities based on levels of criticality and outlined in the validation master plan. 

We can set-up and run the entirety of the validation function so that you can focus on your regular operations Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation 

Biometrix Calibration Offerings for AABB Members 

Turnkey calibration program set-up and operation 

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Calibration master plan: A guidance document for all calibration activities, including calibration frequency, criticality and instrument tolerance. Equipment information forms: Documentation of ID#, serial #, tolerance, range and criticality for each instrument. Calibration: NIST-traceable calibration with as-found and as-left data. 

We can set-up and run the entirety of the calibration function so that you can focus on your regular operations

Biometrix Corporation 800-8908909 www.biometrix.com

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Validation and Calibration for AABB Accreditation Biometrix is your one-stop shop for ensuring that all of your validation and calibration needs are taken care of by trained experts following documented procedures, quickly and cost effectively. Contact: Adam White President/CEO Biometrix Corporation 800-890-8909 x201 [email protected]

Biometrix Corporation 800-8908909 www.biometrix.com

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