对完善药品生产企业数据完整性的思考

发布时间：2018-06-26 20:20

  本文选题：药品生产企业 + 数据完整性　； 参考：《中国药房》2017年13期

【摘要】：目的:为药品生产企业数据完整性管理体系的完善提供参考。方法:根据美国FDA与国家食品药品监督管理总局的相关报道,分析数据完整性问题来源,归纳数据完整性问题的原因并提出解决措施。结果与结论:企业出现数据完整性问题的原因可归结于员工、硬件/软件系统和质量管理体系三方面,各方面与现行标准存在较大差距。建议企业采取差距分析的方法评估现有体系,组建数据完整性管理项目团队并加强人员培训,升级硬件/软件系统保证其安全性、稳定性和有效性,通过建立良好文件规范、数据完整性专项监管体系来优化质量管理体系;此外,企业应建立质量文化、实时关注行业与法规动态,以有效保证数据的完整性。
[Abstract]:Objective: to provide reference for the perfection of data integrity management system in pharmaceutical manufacturing enterprises. Methods: according to the relevant reports of FDA and the State Administration of Food and Drug Administration, the sources of data integrity problems were analyzed, the causes of data integrity problems were summarized and solutions were put forward. Results & conclusion: the reasons of data integrity problems in enterprises can be attributed to three aspects: employee, hardware / software system and quality management system. It is suggested that enterprises should adopt a gap analysis approach to evaluate existing systems, form data integrity management project teams and strengthen personnel training, upgrade hardware / software systems to ensure their security, stability and effectiveness, and establish good documentation specifications. In addition, the enterprise should establish quality culture, pay attention to the industry and regulation in real time, so as to ensure the integrity of data effectively.
【作者单位】： 中国药科大学国际医药商学院;
【分类号】：R95
，

本文编号：2071286