全文预览

2015.9GMP数据完整性和计算机管理培训(精选)

上传者:相惜 |  格式:pptx  |  页数:51 |  大小:0KB

文档介绍
risk of transcription errors?转抄错误从不会发现并组织调查?Transcription errors would never be detected in the event of investigation?同样数据先用铅笔填写,随后抹去, 然后进入使用永久性墨水稍后提供虚假印象按时记录。Р数据完整性问题?Data Integrity Issues (5)РQC实验室数据 Quality Control Data?在系统适应性运行前预检测, ?Pre-testing samples before system suitability runs?非正式样品使用不同的名字,例如“测试/小试、演示、培训等”?Unofficial testing of samples with different file names, such as, Test, Trail, Demo, and training, etc.?其中部分检测结果不符合标准?Some of the testing results failed specifications?所有没有存在网络计算机中而存在个人电脑(办公室)中的数据。?All were saved on puters instead of puter systemР数据完整性问题?Data Integrity Issues (6)Р进入仪器/计算机系统没有适当控制?Access to puter systems is not properly controlled?不同分析员共享密码(同用户名和密码都不行)?Passwords are shared by different analysts?审计追踪功能没有启用或没有审核?Audit trail function was disabled or not reviewed

收藏

分享

举报
下载此文档