This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46...

Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy.  Take patient data of clinical studies, for example.    Data Integrity in general ...

To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall...

In 2016, the Defense Advanced Research Projects Agency (DARPA) of the United States Department of Defense organized the Cyber Grand Challenge.  At this event, fully, autonomous systems with no human interaction attacked each other but also developed patches for...