Digitalization, Internet of Things, and Automation are buzz words of the Information Age. At a rapid pace, technological-driven innovation finds a way of influencing our daily life and impacts the way we experience realities, interact with machines, think, and create value in our business operations; sometimes for the good and maybe sometimes for the not so good. Computers conduct independent analyses in the areas of use and make autonomous decisions based on various artificial intelligence technologies; quite often also with the ability to learn and improve with each operation and interaction.

The pharmaceutical industry with its regulations cannot ignore these trends that open new ways of doing business. The quality professional though might face quite some challenges when it comes to computerized systems using artificial intelligence in regulated environments. Can one use the same approaches for qualification and validation of systems of that kind or will one hit challenges? How would one qualify a controlled system environment (validation, production instance) with a trained artificial network that changes during each interaction? Are there additional or different controls necessary for computerized components that autonomously change structure through learning - like the human brain?

This presentation reflects on the described scenario and shares thoughts on implications during a validation initiative of "automation component"-enabled computerized systems. It pursues the purpose of being thought provoking and might at the current point in time not be able to answer all open questions - but for sure gives a heads-up to what is underway already.