医药化工企业审计追踪的清单化管理  

List Management of Audit Trail in Pharmaceutical and Chemical Enterprises

作　　者：吴仁德 段锋 肖昱 梁国嫔 Wu Rende;Duan Feng;Xiao Yu;Liang Guopin(Jiangxi Drug Inspection Center,Nanchang 330000,China)

机构地区：[1]江西省药品检查员中心,江西南昌330000

出　　处：《广东化工》2023年第10期80-82,共3页Guangdong Chemical Industry

基　　金：江西省药品监督管理局科研项目(2022GL08)。

摘　　要：数据完整性是世界各国药品监督管理机构的检查重点,数据完整性中比较关键的功能或检查点是数据审计追踪,本文从国内和国际的法规要求出发,以数据审计追踪在医药化工企业实验室的应用要求为切入点,从高效液相色谱中的系统、方法、序列、结果等方面探讨了高效液相色谱中审计追踪的清单化管理思路,并对液相色谱审计追踪审核的周期及执行进行了讨论,从而为医药化工企业精密仪器审计追踪清单的建立与审核的管理提供参考建议。Data integrity is the focus of inspection of drug regulatory agencies around the world.The key function or checkpoint in data integrity is data audit tracking.Based on the requirements of domestic and international regulations,this paper takes the application requirements of data audit tracking in the laboratory of pharmaceutical and chemical enterprises as the starting point,and discusses the inventory management ideas of audit tracking in high performance liquid chromatography from the aspects of system,method,sequence and result in high performance liquid chromatography.The cycle and implementation of audit tracking audit of liquid chromatography are discussed,so as to provide reference suggestions for the establishment and audit management of audit tracking list of precision instruments in pharmaceutical and chemical enterprises.

关 键 词：数据完整性 审计追踪 高效液相色谱 清单化管理 医药化工企业 

分 类 号：F426.72[经济管理—产业经济] F239.6