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定制数字解决方案以确保医院药房配方和发行过程中的数据完整性
Marta Durá1, Ángel Sánchez-García1, Daniel Sánchez-García1
1Biomedical Data Science Lab, Instituto Universitario de Tecnologías de la Información y Comunicaciones, Universitat Politècnica de València, Camino de Vera s/n, Valencia 46022, Spain.
Studies in health technology and informatics
|May 17, 2025
概括
本研究介绍了一种软件原型,以确保医院药房运营中的数据完整性,通过药物配方和发行的数字文档来提高患者安全. 定制解决方案旨在提高制药过程中的信息可靠性.
科学领域:
- 制药科学 制药科学
- 医疗信息学 医疗信息学
- 软件工程 软件工程 软件工程
背景情况:
- 数据完整性对于制药生产和医院药房的患者安全至关重要.
- 医院药房的手动文档对数据完整性构成风险.
- 现有的经过验证的数据完整性软件需要适应特定的医院药房工作流程.
研究的目的:
- 提出一个软件定制原型,以确保医院药房配方和发行中的数据完整性.
- 通过提高制药过程文件的可靠性来提高患者安全.
- 在现实世界的医院药房环境中评估软件的准备程度.
主要方法:
- 从设计开始实施ALCOA+原则.
- 应用GAMP5 V模型用于软件开发和验证.
- 利用以人为中心的设计方法来实现用户适应.
- 为医院药房使用案例定制经过验证的数据完整性软件.
主要成果:
- 已经开发了一个用于数据完整性保证的软件定制原型.
- 该原型集成了ALCOA+原则,GAMP5 V模型和以人为中心的设计.
- 该解决方案目前正在医院药房环境中进行评估,以评估其准备程度.
结论:
- 定制软件有潜力支持药物配方和发行数字化.
- 成功验证和实施可以显著提高医院药房的患者安全.
- 这种方法解决了手工制药过程中关键数据完整性的挑战.
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