Legal and regulatory requirements oblige companies to maintain detailed, secure and computer-generated records. A research project involving DHC Business Solutions, the German Research Center for Artificial Intelligence (DFKI) and the medical technology specialist AkknaTek is now investigating how blockchain technologies can be used for these 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 may not be changed. They serve patient and device safety.
A new research project, in which DHC Business Solutions GmbH & Co. KG is working together with the German Research Center for Artificial Intelligence (DFKI) and the medical technology company AkknaTek, is investigating how these requirements can be implemented with blockchain technology and what potential it has.
Blockchain is known to many as a technology for the crypto currency Bitcoin. But the topic is also relevant for many other applications in which the security and integrity of data is at stake. No wonder that the “regulated environment” is also interested in the technology.
“The compliance requirements of FDA or EMA constantly increase the pressure on the legal conformity of the procedures and systems used”, emphasizes Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions. “But we are not only interested in capturing quality-related historical data in a blockchain; we are also interested in the entire life cycle, from the product idea to its use by the customer. Ideally, the blockchain monitors the GxP status in the sense of an automated inspection. Results are fed back into the relevant processes so that, for example, incidents requiring notification do not occur in the first place. In addition, we look at solutions from the exciting field of ‘Machine Learning'”.
The “GxP-Blockchain” research project has a duration of 20 months and is funded by the Central Technology Programme Saar (ZTS) and the European Regional Development Fund (ERDF).