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

Project Information

B-LOCS

Grant agreement ID: 190157602

DOI

10.3030/190157602

Project closed

EC signature date 5 July 2022

Start date 1 July 2022

End date 30 June 2024

Funded under

• The European Innovation Council (EIC)

Total cost

€ 2 272 500,00

EU contribution

€ 1 538 250,00

Coordinated by

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)

Reporting period: 2022-07-01 to 2023-06-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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