QFINITY Workshop on Data Integrity, Copenhagen 2026

On October 13 and 14, 2026, Fleming hosts the Pharma Smart Manufacturing 2026 conference at the Scandic Spectrum in Copenhagen under the banner “From Roadmaps to Real Impact”. Two days focus on how pharmaceutical manufacturers move automation, data platforms and AI from pilot status into validated GMP operations. The program features speakers from Sanofi, Merck KGaA, Novo Nordisk, Roche and Lonza, plus two interactive workshops.

One of the two workshops is led by Oliver Herrmann, GxP Compliance & AI Consultant, Auditor, Chair of the GAMP Europe Steering Committee and CEO of QFINITY. The workshop is titled “Data Integrity & ALCOA++ in Digital Manufacturing Systems: Preparing Data, Systems and People for AI”. At its center is the question of what needs to change in data integrity controls when manufacturing data move between systems and AI starts contributing to quality decisions.

The workshop is interactive: after a short introduction, participants work through a manufacturing case at their tables, and the results are brought together at the end. The frame is set by the current Chapter 4 and Annex 11 requirements, the proposed revisions of both texts and the draft Annex 22 on AI. The workshop runs 90 minutes and is scheduled for the second conference day, October 14, at 11:00 am.

Data integrity and the regulation of AI are part of our daily work. How data integrity is secured in regulated operations is the subject of our service area Data Integrity in GxP-regulated Fields. The regulatory frame is explained on our pages on the Annex 11 revision and the draft EU GMP Annex 22.

Program, brochure and tickets at Fleming (fleming.events)↗

Joining us in Copenhagen? Oliver looks forward to the exchange at the table and on the sidelines of the conference. Or book a call directly.