GMP计算机化系统审计追踪审核探讨  

Discussion of auditing trail of GMP computerized system

作　　者：路佳特 LU Jiate(Merck Pharmaceutical Manufacturing(Jiangsu)Co.,Ltd.,Jiangsu Nantong 226010,China)

机构地区：[1]默克制药(江苏)有限公司,江苏南通226010

出　　处：《上海医药》2019年第15期68-71,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：数据可靠性是近年来世界各国药品监管机构的检查重点,也是发现缺陷项比较多的领域。数据可靠性中比较关键的功能或检查点是审计追踪,本文从欧美法律法规出发,对计算机化系统和关键数据进行分类,基于风险评估和统计学角度,明确审计追踪审核的方法。审计追踪记录的信息很多,应该把有限的资源花在重要和风险高的信息上,保证审核的可操作性和科学性。Data integrity has been the focus of drug regulatory agencies around the world in recent years,and is also the field where there are more defects.The key function or check point in data reliability is audit trail.The computerized systems and key data were classified based on European and American laws and regulations and meanwhile the method of audit trail review was defined based on risk assessment and statistics.Audit tracking records have a lot of information,we should spend limited resource on important and high-risk information so as to ensure the operability and scientific nature of audit trail review.

关 键 词：药品生产质量管理规范 计算机化系统 数据可靠性 审计追踪 

分 类 号：R951[医药卫生—药学]