Towards enterprise-wide pharma 4.0 adoption

The adoption of Industry 4.0 in the pharmaceutical industry is referred to as Pharma 4.0. Pharma 4.0 procures pharmaceutical organizations many significant benefits ranging from operational efficiency to regulatory compliance. This study evaluates existing Pharma 4.0 adoption frameworks in literatur...

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Main Authors: Vincent Junior Phiri, Ilham Battas, Atae Semmar, Hicham Medromi, Fouad Moutaouakkil
Format: Article
Language:English
Published: Elsevier 2025-06-01
Series:Scientific African
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Online Access:http://www.sciencedirect.com/science/article/pii/S2468227625002406
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author Vincent Junior Phiri
Ilham Battas
Atae Semmar
Hicham Medromi
Fouad Moutaouakkil
author_facet Vincent Junior Phiri
Ilham Battas
Atae Semmar
Hicham Medromi
Fouad Moutaouakkil
author_sort Vincent Junior Phiri
collection DOAJ
description The adoption of Industry 4.0 in the pharmaceutical industry is referred to as Pharma 4.0. Pharma 4.0 procures pharmaceutical organizations many significant benefits ranging from operational efficiency to regulatory compliance. This study evaluates existing Pharma 4.0 adoption frameworks in literature and aims to develop a structured and adaptable Pharma 4.0 enterprise-wide adoption conceptual framework. A systematic review was conducted to identify and analyze existing Pharma 4.0 frameworks. The examined frameworks were categorized into Manufacturing and Quality Management, Supply Chain Management, Clinical Trials and R&D Digitalization, Workforce Competence, and Pharma 5.0. Analysis of the identified frameworks reveals that while they offer strategies for digital transformation, they focus solely on specific areas. In response, a conceptual Pharma 4.0 framework is proposed, emphasizing organizational readiness assessment, core technology integration, cybersecurity and data management, system integration, and continuous improvement. This framework provides a practical roadmap for Pharma 4.0 adoption, improving regulatory compliance and operational efficiency. Also, the framework supports a diverse range of pharmaceutical organizations, including small and medium-sized enterprises (SMEs) in Africa and other developing nations. Thus, this study contributes a novel structured framework for enterprise-wide Pharma 4.0 adoption and addresses its key implementation barriers by establishing critical success factors.
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spelling doaj-art-4c5204460ca64bf89c9f2af00847a99b2025-08-20T02:17:20ZengElsevierScientific African2468-22762025-06-0128e0277110.1016/j.sciaf.2025.e02771Towards enterprise-wide pharma 4.0 adoptionVincent Junior Phiri0Ilham Battas1Atae Semmar2Hicham Medromi3Fouad Moutaouakkil4Engineering National High School of Electricity and Mechanic (ENSEM), Hassan II University, Morocco; Research Foundation for Development and Innovation in Science and Engineering (FRDISI), Morocco; Corresponding author at: Vincent Junior Phiri, Engineering National High School of Electricity and Mechanic (ENSEM), Hassan II University, Casablanca, Morocco.Research Foundation for Development and Innovation in Science and Engineering (FRDISI), Morocco; Graduate School of Biomedical Engineering and Health Techniques (SUPTECH), MoroccoResearch Foundation for Development and Innovation in Science and Engineering (FRDISI), Morocco; Graduate School of Biomedical Engineering and Health Techniques (SUPTECH), MoroccoEngineering National High School of Electricity and Mechanic (ENSEM), Hassan II University, Morocco; Research Foundation for Development and Innovation in Science and Engineering (FRDISI), MoroccoEngineering National High School of Electricity and Mechanic (ENSEM), Hassan II University, MoroccoThe adoption of Industry 4.0 in the pharmaceutical industry is referred to as Pharma 4.0. Pharma 4.0 procures pharmaceutical organizations many significant benefits ranging from operational efficiency to regulatory compliance. This study evaluates existing Pharma 4.0 adoption frameworks in literature and aims to develop a structured and adaptable Pharma 4.0 enterprise-wide adoption conceptual framework. A systematic review was conducted to identify and analyze existing Pharma 4.0 frameworks. The examined frameworks were categorized into Manufacturing and Quality Management, Supply Chain Management, Clinical Trials and R&D Digitalization, Workforce Competence, and Pharma 5.0. Analysis of the identified frameworks reveals that while they offer strategies for digital transformation, they focus solely on specific areas. In response, a conceptual Pharma 4.0 framework is proposed, emphasizing organizational readiness assessment, core technology integration, cybersecurity and data management, system integration, and continuous improvement. This framework provides a practical roadmap for Pharma 4.0 adoption, improving regulatory compliance and operational efficiency. Also, the framework supports a diverse range of pharmaceutical organizations, including small and medium-sized enterprises (SMEs) in Africa and other developing nations. Thus, this study contributes a novel structured framework for enterprise-wide Pharma 4.0 adoption and addresses its key implementation barriers by establishing critical success factors.http://www.sciencedirect.com/science/article/pii/S2468227625002406Pharma 4.0FrameworkDigital transformationIndustry 4.0
spellingShingle Vincent Junior Phiri
Ilham Battas
Atae Semmar
Hicham Medromi
Fouad Moutaouakkil
Towards enterprise-wide pharma 4.0 adoption
Scientific African
Pharma 4.0
Framework
Digital transformation
Industry 4.0
title Towards enterprise-wide pharma 4.0 adoption
title_full Towards enterprise-wide pharma 4.0 adoption
title_fullStr Towards enterprise-wide pharma 4.0 adoption
title_full_unstemmed Towards enterprise-wide pharma 4.0 adoption
title_short Towards enterprise-wide pharma 4.0 adoption
title_sort towards enterprise wide pharma 4 0 adoption
topic Pharma 4.0
Framework
Digital transformation
Industry 4.0
url http://www.sciencedirect.com/science/article/pii/S2468227625002406
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