试论符合GLP原则的电子原始资料的归档

Discussion on Filing Electronic Raw Data According with the Principles of GLP

目的本文综述了电子归档的定义、范围、要求、程序和关键问题,概述了GLP机构工作人员在电子归档中的职责,阐述了电子档案的管理和应用。方法检索、阅读和分析与电子归档相关的文献。结果与结论电子归档在国外已经实施多年,许多国家及国际组织颁布了电子归档的指导原则,为了与国际接轨,加速我国实施和制定电子归档的管理规范是档案管理工作的紧迫任务。

Objective This paper summarized the definition,scope,requirements,procedures and key issues of electronic filing,sum up responsibility of GLP agency staff in the electronic filing,described the management and application of electronic records.Methods Search,read and analyze the literatures.Results and Conclusion Electronic filing have been implemented in foreign countries for many years,many countries and international organizations issued guidelines for electronic filing.It is the urgent task of file management to accelerate the implementation and development of electronic filing of management practices.