A4 Refereed article in a conference publication
Engineering Data Architectures for AI/ML Integration in Regulated Manufacturing
Authors: Shubina, Viktoriia; Ranti, Tuomas; Juppo, Anne; Mäkilä, Tuomas
Editors: Herzwurm, Georg; Petrik, Dimitri; Strobel, Gero; Kude, Thomas; Block, Lukas
Conference name: International Conference on Software Business
Publication year: 2026
Journal: Lecture Notes in Business Information Processing
Book title : Software Business : 16th International Conference, ICSOB 2025, Stuttgart, Germany, November 24–26, 2025, Proceedings
Volume: 574
First page : 41
Last page: 57
ISBN: 978-3-032-14517-8
eISBN: 978-3-032-14518-5
ISSN: 1865-1348
eISSN: 1865-1356
DOI: https://doi.org/10.1007/978-3-032-14518-5_5
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Partially Open Access publication channel
Web address : https://doi.org/10.1007/978-3-032-14518-5_5
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/508884805
Self-archived copy's licence: CC BY NC ND
Self-archived copy's version: Publisher`s PDF
Life science, i.e. pharmaceutical and medical device, manufacturers are increasingly exploring artificial intelligence (AI) and Machine Learning (ML) to enhance production quality and regulatory compliance. However, current data handling practices result in data fragmentation, and complex regulatory requirements present barriers to wide implementation. In this study, we conducted 20 qualitative interviews with data architects, AI specialists, and regulatory compliance officers. Our aim was to get a better understanding of the current state of the field, challenges and future outlook in regulated manufacturing, employing the Gioia methodology. Our findings highlight data silos and legacy infrastructures as primary technical barriers, while evolving regulatory frameworks and uncertainties in AI validation create significant compliance challenges. Interviewees emphasized the necessity of unified data architectures and platforms, embedded governance mechanisms, enhanced security, and proactive regulatory operations (RegOps) to enable both innovation and compliance. Based on the interview results, we propose a conceptual framework to guide the design of AI-driven data architectures that bridge fragmented systems and support compliant AI/ML lifecycle management. This study is the first phase of research efforts aiming to implement and validate AI/ML solutions grounded in industry needs.
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