A4 Vertaisarvioitu artikkeli konferenssijulkaisussa
Engineering Data Architectures for AI/ML Integration in Regulated Manufacturing
Tekijät: Shubina, Viktoriia; Ranti, Tuomas; Juppo, Anne; Mäkilä, Tuomas
Toimittaja: Herzwurm, Georg; Petrik, Dimitri; Strobel, Gero; Kude, Thomas; Block, Lukas
Konferenssin vakiintunut nimi: International Conference on Software Business
Julkaisuvuosi: 2026
Lehti: Lecture Notes in Business Information Processing
Kokoomateoksen nimi: Software Business : 16th International Conference, ICSOB 2025, Stuttgart, Germany, November 24–26, 2025, Proceedings
Vuosikerta: 574
Aloitussivu: 41
Lopetussivu: 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
Julkaisun avoimuus kirjaamishetkellä: Avoimesti saatavilla
Julkaisukanavan avoimuus : Osittain avoin julkaisukanava
Verkko-osoite: https://doi.org/10.1007/978-3-032-14518-5_5
Rinnakkaistallenteen osoite: https://research.utu.fi/converis/portal/detail/Publication/508884805
Rinnakkaistallenteen lisenssi: CC BY NC ND
Rinnakkaistallennetun julkaisun versio: Kustantajan versio
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.
Ladattava julkaisu This is an electronic reprint of the original article. |