一种以语义为导向的方法,用于制药行业的维护数字化
Ju Wu1, Xiaochen Zheng2, Marco Madlena3
1Ecole Polytechnique Fédérale de Lausanne (EPFL), Lausanne, 1015, Switzerland; Engineering & Maintenance Department, Merck Serono, Vevey, 1809, Switzerland.
International journal of pharmaceutics
|July 30, 2025
概括
制药行业的数字化转型带来了挑战. 一个新的语义驱动框架增强了维护的数字连续性,与质量4.0原则保持一致,以减少制造缺陷.
科学领域:
- 制药行业 制药行业 制药行业
- 数字化转型 数字化转型
- 质量管理质量管理.
背景情况:
- 由于监管和技术挑战,制药业的数字化转型是复杂的.
- 维护活动对于确保药品质量和运营完整性至关重要.
- 现有的数字化努力在维护资源的数字连续性方面遇到了障碍.
研究的目的:
- 确定制药行业数字化中的关键挑战.
- 为维护活动提出一个语义驱动的数字化框架.
- 为了使药品维护与质量4.0原则和零缺陷制造目标保持一致.
主要方法:
- 识别数字化挑战和问题空间.
- 开发一个语义驱动的数字化框架.
- 使用水样采集的案例研究验证在瑞士默克塞罗诺.
- 介绍框架实施的工具链.
主要成果:
- 经验证了一种可行的语义驱动框架,用于制药维护数字化.
- 关键的功能模块表现出令人满意的性能.
- 开发了一个数字采样助手,支持自动化水采样工作流程.
结论:
- 拟议的框架有效地解决了医药维护数字化中发现的问题.
- 数字采样助手展示了框架的实际应用和潜力.
- 该框架支持制药行业向增强的数字连续性和质量4.0转变.
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