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王广平,宋金奇,谭平. 基于工艺变更制度的医药产业数字化转型升级路径分析[J]. 应用技术学报,2023,23(1):65-72.. DOI: 10.3969/j.issn.2096-3424.2023.01.011
引用本文: 王广平,宋金奇,谭平. 基于工艺变更制度的医药产业数字化转型升级路径分析[J]. 应用技术学报,2023,23(1):65-72.. DOI: 10.3969/j.issn.2096-3424.2023.01.011
WANG Guangping, SONG Jinqi, TAN Ping. Analysis of the digital transformation and upgrading path of pharmaceutical industry based on the process change system[J]. Journal of Technology, 2023, 23(1): 65-72. DOI: 10.3969/j.issn.2096-3424.2023.01.011
Citation: WANG Guangping, SONG Jinqi, TAN Ping. Analysis of the digital transformation and upgrading path of pharmaceutical industry based on the process change system[J]. Journal of Technology, 2023, 23(1): 65-72. DOI: 10.3969/j.issn.2096-3424.2023.01.011

基于工艺变更制度的医药产业数字化转型升级路径分析

Analysis of the digital transformation and upgrading path of pharmaceutical industry based on the process change system

  • 摘要: 医药产业数字化转型是药品安全追溯管理、上市后变更、数据管理的要求和工业化信息化融合等多项政策综合结果,具有降本、提质、增效、提升风险管理能力的重要作用。基于医药制造信息化应用政策引导和数字化技术广泛应用,国内医药产业数字化转型的营商环境目前已得到优化。医药产业数字化转型必然涉及工艺变更的技术改造,实证分析结果显示:从新产品创新阶段融入数字化技术改造是最佳路径。分析了医药产业上市后变更制度于企业数字化应用,设计和构建信息化工程建设、质量管理流程和药物警戒的三维空间结构系统框架,数据、技术、业务流程和组织结构4个转型要素,以及信息化、数字化和智能化3个转型历程,并提出了监管信息化、数字化设计选型、第三方服务和部门协调机制等转型升级路径,以期提供借鉴参考。

     

    Abstract: The digital transformation of pharmaceutical industry is the comprehensive result of multiple policies, such as the drug safety traceability management, post-marketing changes, data management requirements, and integration of industrialization and informatization, which can reduce costs, improve quality, increase efficiency, and promote the drug risk management capabilities. Based on analysis of the pharmaceutical information situation, institutional environment, and the digital technology application, the digital transformation business environment of domestic pharmaceutical industry has been optimized. The digital transformation of the pharmaceutical industry inevitably involves the technological transformation of process changes. The empirical analysis result showed that the best path was to integrate digital technological transformation from the new pharmaceutical innovation stage. The application of the change system in the digitalization of enterprises after the listing of the pharmaceutical industry was analyzed, the three-dimensional structure system framework of the pharmaceutical information engineering construction, drug quality management process and pharmacovigilance was designed and constructed. The framework is composed of four transformation elements of data, technology, business process and organizational structure, and three transformation processes of informatization, digitization and intelligence. Finally, the pharmaceutical transformation and upgrading paths were proposed, such as the supervision informatization, digital design selection, third-party services, and the departmental coordination mechanisms, with a view to providing reference and suggestions for future research.

     

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