Legal requirements and regulatory mandates require companies to maintain detailed, secure, computer-generated records. A research project involving DHC Business Solutions, the German Research Center for Artificial Intelligence (Deutsche Forschungszentrum für Künstliche Intelligenz, DFKI) and medical technology specialist AkknaTek is now investigating how blockchain technologies can be used for these so-called “audit trails.” Secure “audit trails” are one of the core requirements for companies in the so-called “regulated environment”.
Certain events must be documented electronically in a complete and traceable manner, for example, who operated a medical device or a software system, when and how. The records must be complete and must not be altered. They serve to ensure patient and equipment safety. How these requirements can be implemented with blockchain technology and what potential it holds is being explored by a new research project in which DHC Business Solutions GmbH & Co. KG, the German Research Center for Artificial Intelligence (Deutsche Forschungszentrum für Künstliche Intelligenz, DFKI) and the medical technology company AkknaTek are working together. Blockchain is familiar to many as the technology for the cryptocurrency Bitcoin. But the topic is also relevant to many other areas of application where the security and integrity of data is at stake. It is no wonder then that the “regulated environment” is also interested in the technology. “Compliance requirements from the FDA or EMA are constantly increasing the pressure on the legal conformity of the processes and systems used” emphasizes Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions. “But we’re not just interested in capturing quality-related historical data in a blockchain, for example; we’re interested in the entire lifecycle, from product idea to use by the customer. Ideally, the blockchain monitors GxP status in terms of automated inspection. Results are fed back into the relevant processes so that, for example, incidents requiring notification do not occur in the first place. To this end, we are additionally looking at solutions from the exciting field of ‘machine learning’.”
The research project “GxP-Blockchain” is scheduled for 20 months and is funded by the Central Technology Program Saar (Zentrale Technologieprogramm Saar, ZTS) and the European Regional Development Fund (ERDF).
Whitepaper
The research project is documented in the whitepaper “GxP Blockchain: Possible Applications for Blockchain Technology in the Regulated Environment” and can be obtained here….