Computerized systems have become the backbone of GxP operations, yet validation practices around them face pressure from two directions. On one side, regulators are modernising expectations through draft revisions to EU GMP Annex 11 and Chapter 4 and a proposed new Annex 22 on Artificial Intelligence, together with the move towards Computer Software Assurance, signals a shift from document volume towards demonstrated assurance and critical thinking. On the other side, technology itself is moving faster than most quality systems were designed to handle, with cloud and SaaS platforms, continuous delivery, and now artificial intelligence and machine learning entering GxP-relevant processes.
Date: 3 – 4 March 2027| Munich, Germany
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