药检机构实验室信息化建设中ELN系统应用的探讨

Exploration on Application of ELN in Informatization of Drug Control Institute

目的探讨药检机构实验室信息化建设中电子实验室记录本(ELN)系统的选型和实施。方法结合我国药检机构实验室信息化平台建设的现状,论述ELN系统的意义和具体功能,并提出如何在药检系统信息化中进行ELN系统的选型。结果作为第三方检测实验室的药检机构,在ELN的选型上应该区别于医药生产行业的ELN选型方式,需要选择一款灵活的ELN,同时选择适应日常检验和分析的ELN产品。结论选择灵活的可定制的ELN产品,能够满足药检实验室日常检验和分析的需求,适用于药检行业分析实验室的解决方案。

Objective To discuss the selection and implementation of ELN system in the informatization process of institutes for drug control. Methods Combining the history and current status of informatization in drug control, the article analyzed the significance and function of ELN, and discussed how to select a suitable ELN system for the institute for drug control. Results As a third party test lab, different from the manufacturing QC lab, the institute for drug control should choose a flexible ELN system which can cover both routine inspection and analytical development. Conclusion A flexible, customizable ELN system, which can satisfy the requirements for analytical development, is suitable for informatization construction of the institute for drug control.