数据完整性问题
Data Integrity Issues(1)
FDA检查发现事实 FDA Observed Facts:
未及时记录 Not recording activities contemporaneously
倒签日期 Backdating
没有原始记录或记录造假 No raw data and/or fabricating data
复制历史数据作为新数据 Copying existing data as new data
重复进样和预检测 Re-running samples and pre-testing
丢弃数据(无效数据未说明) Discarding data (invalid data
without justification)
评论0
最新资源