RAYA 2026 – Introduction Key Note on Robotics And Automation and Regulatory Requirements
At the ISPE Robotics and AI and RAYA event, Dr. Roland Bauer opened with a clear perspective on how regulatory inspections are evolving alongside massive data streams and artificial intelligence. While core risk based validation remains mandatory, authorities increasingly expect manufacturers to use collected data proactively for continuous process improvement and optimization. In the eyes of an inspector, data is an active, dynamic resource rather than a static compliance archive, placing the responsibility on regulated users to prove that data driven decisions translate into tangible operational control.
Managing this flow requires boundaries between raw records and derived metrics. Bauer stressed that derived data must remain representative and fall within clear specifications, especially across extended timeframes where gradual operational drift occurs. Throughout this chain, Qualified Person oversight remains essential. At Critical Control Points, companies must define exact data quality criteria and directly involve decision makers who understand the complex interaction between the product, process, and automated machinery.
When addressing artificial intelligence, Bauer reminded attendees that algorithms represent a practical tool rather than a fundamentally new methodology. The technology does not alter regulatory baselines, and intended use dictates the required validation depth. This cautious stance reflects the joint guiding principles from the European Medicines Agency and the United States Food and Drug Administration, prioritizing human centric design, multidisciplinary expertise, and the classic plan, do, check, and act cycle.
Health authorities are actively updating their institutional toolkits through initiatives like the EMA Quality Innovation Group, alongside ongoing revisions to Chapter 4 on documentation, Annex 11 on computerized systems, and the drafting of Annex 22 for artificial intelligence. While routine surveillance programs continue as established, regulatory teams are expanding their internal technical expertise to evaluate advanced models directly, increasingly collaborating through cross border joint inspections.
