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

Informazioni relative al progetto

B-LOCS

ID dell’accordo di sovvenzione: 190157602

DOI

10.3030/190157602

Progetto chiuso

Data della firma CE 5 Luglio 2022

Data di avvio 1 Luglio 2022

Data di completamento 30 Giugno 2024

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 2 272 500,00

Contributo UE

€ 1 538 250,00

Coordinato da

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)

Periodo di rendicontazione: 2022-07-01 al 2023-06-30

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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