ISPE Pharma 4.0 Conference Berlin 2026

We are pleased to be part of the 2026 ISPE Pharma 4.0 & Biopharma Conference!

The conference takes place on 10-11 December 2026 in Berlin – a central European meeting point for the digital transformation of the pharmaceutical industry. You can also attend virtually.

QFINITY on stage

In his talk, Oliver Herrmann shows how AI reshapes Quality Assurance in regulated environments – and why human oversight must be a designed structural element, not an end-of-line check.

Human Oversight by Design: Progressive QA for AI-Enabled GxP Systems

Oliver Herrmann (QFINITY)

AI does not just add tools to GxP. It changes how computerized systems behave. Execution moves from operation to supervision. Deterministic logic gives way to probabilistic output. This does not lower the demand for Quality Assurance. It raises it.

Quality no longer comes from validating a system in isolation. It emerges from the interaction of business processes, data, software, interfaces and decision structures. QA stops being a downstream control and becomes the architect of the landscape it once only inspected.

The GAMP AI Guide draws the distinction that carries this shift: the AI subsystem is not the computerized system, and the model is a component. What you validate is the system, against its intended use – not the model in the abstract. Human oversight is where this becomes concrete. Treated as a check at the end of the line, it controls nothing; designed into the architecture, it holds. Oversight is not a stage you add once the system runs – it is a property you build before it does.

AI runs on statistical inference. It produces plausibility, not understanding. Between a plausible output and a correct decision sits a structural gap. It does not close by trusting the model – it closes by design. Progressive QA is the answer to rising speed and complexity, managing the process, data and system layers at once. The core message: capability is not reliability – and the work of QA is to make that difference visible before the system does.

Program and registration at ISPE (ispe.org)↗

Attending in person? Reach out – we look forward to connecting.