药品检验电子数据归档和电子档案管理研究

Research on Electronic Data Archiving and Electronic Files Management of Drug Inspection

目的:面对目前药品检验机构档案管理所面临的多重压力,探讨利用药品检验电子数据直接归档的方法,以电子档案管理形式应对药品检验机构档案管理困境,为药品智慧监管提供大数据基础支撑。方法:以国家级药品检验机构Z机构为例,对药品检验数据归档和档案管理的基本情况和管理现状进行分析,发现问题并提出解决策略。结果与结论:药品检验机构应在各相关部门统筹协调、共同推动的情况下,制定统一的标准规范来实现药品检验数据以电子文件形式直接归档,推进药品检验机构的数据管理更加适应药品质量安全和智慧监管的发展。

Objective:In the face of the multiple pressure on the file management of drug inspection institutions at present,this paper discusses how to use the electronic data of drug inspection to file directly.Electronic files are used to deal with the predicament of file management of drug inspection institutions in order to provide a big data foundation for the intelligent supervision of drugs.Method:Taking the national drug inspection institution Z as an example,tthe basic situation of drug inspection data archiving and file management as well as the management status were analyzed,and then problems were found and solutions were proposed.Results and Conclusion:Under the overall coordination and joint promotion of relevant departments,drug inspection institutions should formulate unified standards and specifications to realize the direct archiving of drug inspection data in the form of electronic files,and promote the data management of drug inspection institutions so as to better adapt to the development of drug quality,safety and intelligent supervision.