Fully digital Blockchain-based Laboratory Operations Control System for real-time and audit-proof Good Manufacturing Practice conformity

Información del proyecto

B-LOCS

Identificador del acuerdo de subvención: 190157602

DOI

10.3030/190157602

Proyecto cerrado

Fecha de la firma de la CE 5 Julio 2022

Fecha de inicio 1 Julio 2022

Fecha de finalización 30 Junio 2024

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

€ 2 272 500,00

Aportación de la UE

€ 1 538 250,00

Coordinado por

ARXUM GMBH
Germany

Periodic Reporting for period 1 - B-LOCS (Fully digital Blockchain-based Laboratory Operations Control System for real-time and audit-proof Good Manufacturing Practice conformity)

Período documentado: 2022-07-01 hasta 2023-06-30

Resumen del contexto y de los objetivos generales del proyecto

BLOCS aims at monitoring the analyses performed on the laboratory software and at detecting whether the raw data have been altered by anomalies resulting from protocol errors or actions that do not comply with the GMP rules. This process guidance can be extended to manual processes. BLOCS records in real time the events that occur on analysis raw data of a lab software and registers them on a blockchain. In order to properly report the status of the analysis, the business logic of each is immutably recorded. Any deviation is reported and triggers real time configurable alarms. The strength of this approach lies in the trust provided by the immutability of data storage on the blockchain. It serves the business logic to decide whether the latest event impacts the validity of a laboratory analysis performed. There is no way to override the BLOCS and the history of the blockchain.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

Constantly working on UI/UX elements of the BLOCS portal, introduced new style according to marketing strategy. Splitting the application functions into modules and switching to the NestJS framework for improved scalability, performance, and issue fixing. Developing a process workflow configurator tool to execute tamper-proof documentation based on smart contracts and integrate it into the BLOCS portal application. Spin up a new blockchain based on Google and create a testing plan for performance, security and scalability.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

Arxum has advanced the solution towards a holistic approach to digital compliance documentation in the life science sector through the intelligent combination of software patterns and technologies. A first commercialisation is underway with selected pilot customers.

ARXUM BLOCS Solution Overview

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