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Karin Bechberger
By Karin Bechberger on November 14, 2022

Authors: Karin Bechberger and Julia Ahlhelm

With an increasing amount of data and new technologies, there is a need to differentiate between wasting time and putting effort into non-value-added activities instead of ensuring fitness for the intended use of a computerized system. It is for this reason that the concept of critical thinking was added as an attachment to the 2nd edition of GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, to enhance risk management in computer system validation.

Thomas Cullum
By Thomas Cullum
on October 25, 2022

Authors: Thomas Cullum & Julia Ahlhelm

Artificial intelligence (AI) and machine learning (ML) algorithms have been significant drivers of innovation in recent years, allowing for new applications for data analytics and automation. In many industries, AI and ML have already delivered evidence of their importance in improving and optimizing processes. For this reason, their implementation in the pharmaceutical industry is essential. 

Roberto Orlandini
By Roberto Orlandini
on October 24, 2022

A number of industries are exploring the possible advantages of incorporating blockchain as a highly secure form of transmitting data. However, until recently, there has been little guidance on how the pharma industry might adopt blockchain technology without fear of putting patient safety, product quality, and data integrity at risk.