Satisfying Validation and

Calibration Requirements
for AABB Accreditation

Biometrix Corporation 800-890-

8909
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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 800-890-

8909
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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 800-890-
8909
www.biometrix.com 3
Validation and Calibration for AABB
Accreditation
 Specific cGMP requirements
 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 800-890-

8909
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Validation and Calibration for AABB
Accreditation
Critical equipment for transfusion and cellular therapy
laboratories

 Freezers  Water Baths

 Refrigerators  Sealers
 Plasma Extractors  Data Loggers
 Centrifuges  Chart Recorders
 Incubators  Biohazard Cabinets
 Analyzers
 Balances
 Rotators
 Syringe Pumps
 Automated Core Blood
Processors
…and more

Biometrix Corporation 800-890-

8909
www.biometrix.com 5
Validation and Calibration for AABB
Accreditation
 Biometrix Validation Offerings for AABB Members
 Turnkey validation program set-up and operation
 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 800-890-

8909
www.biometrix.com 6
Validation and Calibration for AABB
Accreditation
 Biometrix Calibration Offerings for AABB Members
 Turnkey calibration program set-up and operation
 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 800-890-

8909
www.biometrix.com 7
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
awhite@biometrix.com

Biometrix Corporation 800-890-

8909
www.biometrix.com 8