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

B-LOCS 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. B-LOCS records in real time the events that occur on the files from the lab software and sends them to a smart contract on a blockchain. In order to properly report the status of the analysis, the business logic of each software (for file creation or invalid action events - e.g. file deletion) is recorded immutably in a Smart-Contract. Any deviation is reported and triggers real time configurable alarms. The strength of this approach lies in the trust provided by the Smart-Contract running on the blockchain: it contains the business logic that decides whether the latest event impacts the validity of a laboratory analysis performed. There is no way to bypass this GMP-relevant business logic; no way to override the B-LOCS and the history of the blockchain.