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.
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.