If you are a drug manufacturer dealing with strict GMP audit requirements — this project developed a blockchain-based control system that ensures raw data cannot be altered without detection. This guarantees that every batch of medicine is produced according to the rules.
Blockchain-based Digital Compliance System for Laboratory Quality Control and Audit Proofing
Imagine a digital notary that watches every single change made to a lab test result in real-time. If someone tries to sneakily change a number or delete a file, the system catches it instantly and sounds an alarm. It creates an unchangeable history book of every action, making it impossible to fake results or hide mistakes.
What needed solving
Laboratories struggle to prove that raw data hasn't been altered, making GMP audits risky. Manual documentation and software gaps allow for protocol errors or unauthorized data changes that threaten patient safety.
What was built
A blockchain-based portal with a process workflow configurator and smart contracts that record lab software events in real-time to prevent data tampering.
Who needs this
Who can put this to work
If you are a clinical research organization dealing with data integrity risks during analysis — this project developed a real-time monitoring tool that records events on a blockchain. This prevents protocol errors from compromising the validity of laboratory analyses.
If you are a diagnostic laboratory dealing with the risk of manual documentation errors — this project developed a process workflow configurator that executes tamper-proof documentation. This ensures patient safety by maintaining an immutable record of all test steps.
Quick answers
What is the cost or pricing model for B-LOCS?
Based on available project data, specific pricing or cost details are not provided.
Can this system be scaled for large industrial laboratories?
Yes, the project involved switching to the NestJS framework specifically to improve scalability and performance for the application functions.
Who owns the IP and how is licensing handled?
Based on available project data, specific licensing terms are not mentioned, but the project is coordinated by ARXUM GMBH.
How does this help with regulatory compliance?
It ensures Good Manufacturing Practice (GMP) conformity by recording events on a blockchain, making the documentation audit-proof and immutable.
How is the system integrated with existing lab software?
The system monitors analyses performed on laboratory software by recording events that occur on the raw data files in real time.
Who built it
The project is driven by a highly focused industrial group consisting of 3 SMEs from Germany, Bulgaria, and France. With a 100% industry ratio and no university or research institute involvement, the consortium is structured for rapid commercialization rather than academic study, utilizing a total EU contribution of EUR 1,538,250.
Contact ARXUM GMBH in Germany for commercial pilot opportunities.
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