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AssureImmune has set the highest standards for quality. Our quality control program is the heart of our business.
We are registered with the FDA and have set a goal to qualify for accreditation and/or certification with leading organizations such as AABB (formerly called the American Association of Blood Banks), ISO (International Organization for Standardization), and the Foundation for the Accreditation of Cellular Therapy (FACT). The accreditation process for these organization take months if not years of consistent performance in order to achieve.
Towards this goal AssureImmune has hired scientists and technologists, who are highly experienced in FDA regulatory processes and blood banking regulations as well as cGMP Quality Systems. We have implemented a sophisticated information technology program and a rigorous Enterprise Resource Planning system to track and document process and quality activities to ensure compliance with world class operating procedures. |