Ivan Lugovoi: Agentic AI in Regulated Quality Operations Measuring Productivity & Task Restructuring in Pharma

Title: Agentic AI in Regulated Quality Operations: Measuring Productivity and Task Restructuring in Pharmaceutical Manufacturing

Pharmaceutical manufacturers produce a large volume of mandatory quality documents under EU GMP requirements. Product Quality Reviews, batch release certificates, and supplier audit reports are prepared manually by quality assurance employees. Regulatory expectations for computerised systems, set out in EU GMP Annex 11 and the draft Annex 22, have so far kept generative AI out of these applications, because the output of a probabilistic model cannot be qualified with the methods developed for deterministic software.

This seminar presents an ongoing applied research project built around a controlled and auditable process in which agentic AI assembles GMP documents from source records through defined steps, while the responsible person retains review and signature. The process is currently in use at two European manufacturing sites. The talk covers the regulatory framing, the process architecture, and first evidence on where preparation time is spent and where it is saved.
The second purpose of the seminar is to open the resulting data to colleagues at KLU. The deployment is instrumented at the level of the individual document component. The system records preparation time per component, source retrieval, human corrections and overrides, rework, and review outcomes. This yields task-level measurement of the division of labour between human and agentic AI in regulated knowledge work. Faculty members and doctoral students are invited to develop research questions on this data, including field experiments with randomised assignment of process configurations across documents and product families, and case studies at participating manufacturing sites. Conditions of data access and confidentiality will be discussed at the end of the session.
 

Prof. Dr. Ivan Lugovoi is an Assistant Professor of Medical and Pharmaceutical Supply Chain Management at Kühne Logistics University. He received his PhD in Management Science at HEC Paris, France. Before joining Kühne Logistics University in 2022, Prof. Lugovoi was a Post-Doc Researcher at Ohio State University, USA.

Prof. Lugovoi uses unique longitudinal datasets to study topics in operational management such as process innovation, procurement auctions, drug shortages, and standard setting. His work has been published in Manufacturing & Service Operations Management and Production and Operations Management. His paper "Manufacturing and Process Innovation in the Pharmaceutical Industry" was awarded Best Informs Times paper of the month in June 2022. The overarching goal of Prof. Lugovoi's research is to establish a solid theoretical and empirical base for reshoring pharmaceutical production, improving the efficiency of the pharmaceutical supply chain, and speeding up new drug discovery.