Frank Henrichmann on trust in AI for computerized system validation

Frank Henrichmann, Senior Executive Consultant at QFINITY, spoke with Life Science Connect about the use of AI in computerized system validation. The interview appeared on September 4, 2026, published simultaneously on Pharmaceutical Online, Bioprocess Online and Biosimilar Development.

In the interview, he sets out which validation tasks can be handled reliably by machine. These include checking completeness, tracing requirements to evidence and comparing documents for consistency. It becomes more delicate where someone has to judge whether a piece of evidence is adequate or how a deviation should be assessed. Those judgments stay with people.

He describes two effects as the real danger: automation bias and cognitive ease. Anyone reading plausibly worded suggestions reviews them less rigorously, and that is precisely why putting a person into the process is not enough. It takes independent technical controls that hold even when human review slips. As the methodological framework, he points to the GAMP 5 Second Edition.

Jon O’Connell of Life Science Connect conducted the interview. You can read it here.