制药4.0背景下关于智慧文件管理系统的探讨

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。

Discussion on Intelligent File Management System in Pharmaceutical 4.0

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 4W(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.