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
BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026
We are glad to be at the 9th BPD Biopharmaceutical Bioprocess Development Summit in Shanghai!
The summit runs August 6-7, 2026 in Shanghai – China’s benchmark event for biopharmaceutical process development, from research to commercial manufacturing. Since 2017 it has connected the entire CMC value chain; the 2025 edition drew more than 5,500 attendees and over 160 speakers. The AI FOR PHARMA Conference 2026 runs alongside it.
QFINITY on stage
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory) are pleased to speak at both conferences on August 6: at the BPD Summit itself on the shift in EU GMP regulation, and at the parallel AI FOR PHARMA Conference on how adaptive AI only becomes GMP-ready under control.
Shifting the EU GMP Regulatory Paradigm – Annex 11 and Annex 22 Drafts
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory)
“Global Expansion & Globalization” track. For companies expanding into European markets, the regulatory ground is shifting: the revised EU GMP Annex 11 and the new Annex 22 draft reshape how computerized systems – and, increasingly, AI – are assessed in GxP environments. The talk maps out what quality, IT, and regulatory teams need to prepare for.
Adaptive AI Without Control is Not GMP – From Potential to Controlled Biopharma
Digital Compliance Architecture for Trustworthy Adaptive AI-Enabled Systems from Process Development to GxP Manufacturing
Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting & Advisory)
AI FOR PHARMA Conference. Adaptive AI systems change their behavior as new data comes in – exactly what makes them powerful and hard to keep in check. Without robust control, that potential never reaches GMP. The talk outlines a digital compliance architecture that keeps adaptive, AI-enabled systems trustworthy and verifiable, from process development through to GxP manufacturing.
Meet us in Shanghai – we look forward to connecting in person.
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.