Digitalisation in European pharmaceutical manufacturing: Towards an operational blueprint

Fahom, Constantin, Wynn, Martin G ORCID: https://orcid.org/0000-0001-7619-6079 and Allison, Jordan ORCID: https://orcid.org/0000-0001-8513-4646 (2026) Digitalisation in European pharmaceutical manufacturing: Towards an operational blueprint. Innovation and Emerging Technologies, 13 (254000). pp. 1-17. doi:10.1142/S2737599426500064

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Abstract

Digitalisation has become a strategic priority across European pharmaceutical manufacturing, yet many initiatives remain fragmented and poorly embedded in routine practice. Drawing on academic, regulatory and industry literature, this study develops a five-dimension provisional conceptual framework (PCF) and uses it to inform a questionnaire completed by 51 practitioners from 35 pharmaceutical organisations. Structured responses were analysed descriptively, while open-text responses were examined thematically. The findings indicate that digitalisation outcomes were shaped less by technology availability than by integration, data quality, governance, ownership, validation readiness and adoption support. Respondents associated digitalisation with stronger visibility, traceability, coordination and compliance support, but these benefits depended on digital systems becoming trusted and usable in daily workflows. These insights allowed the PCF to be developed into an operational blueprint for pharmaceutical digitalisation, sequencing prerequisites, aligning functions around inspection-ready digital routines and diagnosing implementation breakdowns. The findings will be of interest to researchers examining digitalisation in industry contexts and to practitioners in the pharmaceutical manufacturing sector charged with overseeing digitalisation projects.

Item Type:	Article
Article Type:	Article
Uncontrolled Keywords:	Pharmaceutical Industry; Digitalisation; Operational Blueprint; Barriers; Success Factors
Subjects:	Q Science > QA Mathematics > QA75 Electronic computers. Computer science T Technology > T Technology (General)
Divisions:	Schools and Research Institutes > School of Business, Computing and Social Sciences
Depositing User:	Martin Wynn
Date Deposited:	21 Jul 2026 09:32
Last Modified:	21 Jul 2026 09:45
URI:	https://eprints.glos.ac.uk/id/eprint/16434

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