Method and system for quality management in therapeutic...

G - Physics – 06 – F

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G06F 19/00 (2006.01) G06F 15/00 (2006.01)

Patent

CA 2268347

The invention concerns a method for quality management in a therapeutic process, said process comprising steps of sampling cells from a patient, specific treatment of these cells according to a specific treatment protocol, and reinfusion into this patient of said treated cells. This method consists in: steps of identifying entities involved in the therapeutic process; steps of sequential and conditional validation of the therapeutic process; and steps of quality control. The steps of identification, validation, automatic computation (unit conversion, computation of the concentration values and of volumes) and control are carried out for each batch of samples taken from a given patient. The invention is applicable in treatment laboratories, in particular for cell therapy.

Procédé de gestion de qualité dans un processus thérapeutique, ce processus comportant des étapes de prélèvement de cellules sur un patient, un traitement spécifique de ces cellules selon un protocole de traitement spécifique, et une réinjection sur ce patient desdites cellules ainsi traitées. Ce procédé comprend: des étapes d'identification des entités impliquées dans le processus thérapeutique, des étapes de validation séquentielle et conditionnelle des étapes du processus thérapeutique, et des étapes de contrôle de qualité. Les étapes d'identification, de validation, de calculs automatiques (conversion unités, calculs de concentrations et de volumes) et de contrôle sont réalisées pour chaque lot de prélèvement effectué sur un patient donné. Utilisation dans des laboratoires de traitement, notamment pour des thérapies cellulaires.

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