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浅析新版GMP要求下制药企业如何实施电子记录
引用本文:康恺. 浅析新版GMP要求下制药企业如何实施电子记录[J]. 机电信息, 2012, 0(23): 27-29
作者姓名:康恺
作者单位:中国药科大学国际制药商学院,江苏南京,210009
摘    要:探讨计算机系统下的电子记录GMP管理问题,通过对电子记录的内容、使用特性和GMP管理特征进行研究,介绍了电子数据采集系统,总结分析制药生产企业电子记录的GMP管理中存在的问题并提出对策建议。

关 键 词:电子记录  数据采集系统  计算机系统  GMP

Analysis of new GMP requirements for pharmaceutical companies how to implement the electronic records
Kang Kai. Analysis of new GMP requirements for pharmaceutical companies how to implement the electronic records[J]. Mechanical and Electrical Information, 2012, 0(23): 27-29
Authors:Kang Kai
Affiliation:Kang Kai (International Business School, China Pharmaceutical University, Nanjing 210009, China)
Abstract:Discussion of the GMP management of electronic records in the computer system,by the contents of the study of electronic records,the use of the characteristics and GMP characteristics to introduce of electronic data acquisition system.Analyzed the problems in the GMP pharmaceutical production enterprise electronic records management and proposed suggestions.
Keywords:electronic records  data acquisition system  computer system  GMP
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