省级药品(含医疗器械、化妆品)现场检查管理工作难点与智慧监管创新的实践

Practice on Difficulties in Provincial Certification Inspection Management of Drugs and Medical Devices and Innovation of Intelligent Supervision

分析梳理了省级药品(含医疗器械、化妆品)现场检查工作中存在的问题和难点,提出了运用信息化手段破解这些问题和难点的路径和方法,并进行了具体的实践运用。建立的药品(含医疗器械、化妆品)现场检查管理系统运用“互联网+”技术使药品现场检查由单一流程管理向多维数据沉淀与驱动的智慧管理转型,基本实现“监管信息汇集”“检查耙向提示”“音像证据锁定”“各端‘实时’联动”“电子记录留痕”“风险等级生成”的全过程监管,为药械化现场检查由传统管理向高效能智慧管理转化打下了基础,为“两品一械”现场检查监管和日常监管提供了一个全新的技术手段。

Based on the analysis of difficulties in inspection management of drugs,medical devices and cosmetics,provided a information technology to solve those problems,and applied in practical work.Established the inspection management system of drugs using"Internet plus"technology,to change one single process management into multidimensional data driven processes of inspection management of drugsmedical devices and cosmetics.The whole process of supervision has been basically achieved with pooling supervision information,tipping inspection points,locking audio and visual evidence,real-time interaction of all the terminal drivers,archiving electronic records and warning risks level.It is the basis for changing of drug inspection management from traditional to intelligent,and provided a brand new technology with inspection and day-to-day supervision of drugs,medical devices and cosmetics.