January / February 2023


This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition,...


As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.