QFINITY · News · Insights & Events
Shaping the regulated quality of tomorrow.
Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
Latest articles
QFINITY at the ISPE AI Summit 2026: Advancing Practical AI Applications in GxP
The first ISPE AI in Life Sciences Summit – Powered by GAMP put one question at its centre, a question QFINITY has worked on for years: how do you move AI in GxP environments from experiment to validated, responsible use? QFINITY was on site and helped shape the content – among other things with a workshop on working with AI suppliers.
The Summit turned on a core question for regulated life sciences: what changes when AI enters the picture – and what does not? Collaboration between the regulated user and the supplier was always demanding: different vocabularies, quality brought in too late, short-notice changes in SaaS services. AI sharpens these familiar challenges and adds new ones – dynamic models, model drift, a higher relevance of data, ongoing performance monitoring.
The answer, however, is not a new discipline: it is the proven GAMP 5 key principles, critical thinking and a risk-based approach – the right mix of flexibility and rigor.
Four blind spots in AI supplier relationships
How concrete this gets became clear in the workshop, drawing on real gaps that recur in AI supplier relationships:
The decisive question behind every gap: what would you put in front of an inspector to justify your validation strategy?
The regulatory framework for this is taking shape right now: the draft EU GMP Annex 22 requires the regulated user to review the documentation – regardless of whether the model is trained in-house or by a supplier. Methodological orientation comes from the ISPE GAMP Guide: Artificial Intelligence (2025), and the EU AI Act draws a further line with its distinction between provider and deployer. Specific guidance on AI supplier management is still rare – and this is where QFINITY works at the leading edge.
That QFINITY helps shape this development is no coincidence: as chair of the GAMP Global Steering Committee, Frank Henrichmann, Senior Executive Consultant at QFINITY, is close to where these guidelines take form. The real value, however, is created where QFINITY translates this still-young framework into robust practice – from AI experiment to validated, audit-ready use.
ISPE Pharma 4.0 & Biopharma Conference with QFINITY | December 10-11, 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.
Official GAMP 5 Basic Principles Training with QFINITY | October 22-23, 2026
Frank Henrichmann (QFINITY) will lead the official two-day GAMP 5 Basic Principles training in person at the ISPE Annual Meeting 2026 in National Harbor (Washington, D.C.) – a practical introduction to risk-based compliance for computerized systems based on the GAMP 5 Guide (Second Edition). October 22-23, 2026, Gaylord National Resort, National Harbor (Washington, D.C.), USA.
The official ISPE training course “Basic Principles of Computerized Systems Compliance” teaches the internationally recognized methods for ensuring that computerized systems in the pharmaceutical, biotech, and medical device industries comply with regulatory requirements and are “fit for intended use” – directly from the GAMP 5 Guide, Second Edition.
Contents
Format: 2-day in-person course (8:30 a.m.-4:30 p.m. EDT), Fundamental level, language: English, 1.3 ISPE CEUs. Trainer: Frank Henrichmann, Senior Executive Consultant at QFINITY and Chair of the Global GAMP Steering Committee. The training immediately follows the ISPE Annual Meeting & Expo (October 18-21).
Course details and registration via ISPE (ispe.org)↗