日本PDA学術誌 GMPとバリデーション
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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医薬品製造におけるDX人材育成に関する検討
日本PDA製薬学会 関西勉強会 デジタルトランスフォーメーション(DX)グループ高井 謙次峠 茂樹集 弘就上久木田 務落合 宏則賀屋 拓郎後藤 健太白木澤 治中島 潤外尾 英隆山本 和秀柳澤 徳雄
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2026 年 28 巻 1 号 p. 54-68

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Proposal for Digital Talent Development to Promote Digital Transformation in Pharmaceutical Manufacturing. Japan’s digital transformation (DX) is considered to be lagging behind Western countries, particularly in pharmaceutical manufacturing, where conservative corporate culture and regulatory complexity hinder progress. This proposal emphasizes human resource development as the key to successful DX implementation. We define seven essential roles—Business Architect, Designer, Data Scientist, Software Engineer, Cybersecurity Specialist, Data Steward, and CSQA (Computer System Quality Assurance)—and outline their responsibilities, tasks, and required skills. By fostering these roles, pharmaceutical companies can enhance DX quality, strengthen global competitiveness, and establish sustainable organizational frameworks. This proposal presents a conceptual framework aimed at providing practical guidance and recommendations for accelerating DX in the pharmaceutical industry.

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