制药4.0背景下关于智慧文件管理系统的探讨.docVIP

制药4.0背景下关于智慧文件管理系统的探讨 邓婷 刘梦 武小赟 胡荣 郑小红 重庆市药品技术审评认证中心 重庆药友制药有限责任公司 重庆医药高等专科学校药学院 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 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。 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; 作者简介：邓婷, 主管药师, 从事药品审评认证工作, Tel E-mail 作者简介：郑小红, 博士, 从事抗微生物新药研发工作, Tel E-mail:zxh10760@163.com 收稿日期：2017-06-20 基金：重庆市教育委员会科学技术研究项目 (KJ1726395) Discussion on Intelligent File Management System in Pharmaceutical 4.0 DENG Ting LIU Meng WU Xiao-yun HU Rong ZHENG Xiao-hong Center For Drug Inspection and Evaluation; Yao Pharma Co.Ltd.; Department of Pharmacy, Chongqing Medical and Pharmaceutical College; Abstract： 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 internationa