摘要
本文以药品生产企业为例,探讨智慧文件管理系统的定义、需求,再结合国内外制药行业药品生产质量管理规范（GMP）检查缺陷项目现状和数据完整性的要求,以数据的4W（who,when,where,what）属性为基础,探讨智慧化文件系统的构建思路,通过3个设计的运用举例来展现该系统具备搜索和逻辑运算功能的显著特点,并预见该系统的优点和实施难点。该系统将有利于制药4.0背景下的工厂实现高效、便捷地利用各类文件进行信息检索和逻辑运算,使得药品研发和注册工作更加科学、系统、有序,同时也利于国际标准化录入和建立绿色低碳、信息化、智能化、国际化的制药核心技术平台。
Firstly,the authors took pharmaceutical production enterprises as an example to discuss the definition and requirements of intelligent file management system, and then combined with the domestic and international status of good manufacture practices（ GMP） inspection defects in the pharmaceutical industry and the requirements of data integrity,the construction idea of intelligent file system was investigated based on the 4 W（ who,when,where,what） attribute of data. This paper also showed the characteristics of this system with searching and logical operation functions through the three designed examples. Finally, the advantages and implementation difficulties of the system were foreseen. The system will benefit the factory under the background of pharmaceutical 4. 0 to achieve efficient and convenient use of all kinds of documents for information retrieval and logic operations,it will promote the drug research and registration work to be more scientific and systematic,but also be conducive to the international standard input and the establishment of pharmaceutical core technology platform.
作者
邓婷
刘梦
武小赟
胡荣
郑小红
DENG Ting;LIU Meng;WU Xiao-yun;HU Rong;ZHENG Xiao-hong(Center For Drug Inspection and Evaluation, Chongqing 401120, China;YaoPharma Co. Ltd., Chongqing 401121, China;Department of Pharmacy, Chongqing Medical and Pharmaceutical College, Chongqing 400030, China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2018年第1期186-190,共5页
Chinese Journal of Experimental Traditional Medical Formulae
基金
重庆市教育委员会科学技术研究项目(KJ1726395)
重庆市卫生和计划生育委员会医学科研面上项目(20142120)
重庆医药高等专科学校校级重点课题项目(ygz2016102)
关键词
制药4.0
智慧文件管理系统
药品生产质量管理规范
药品生产企业
逻辑运算
标准操作规程
pharmaceutical 4.0
intelligent file management system
good manufacture practices
pharmaceutical production enterprises
logical operation
standard operating procedures
