EDC越来越普及,法规也越来越关注数据的完整性,而审计追踪(audit trail)可以记录电子数据相关的who、what、when、why,是一种非常重要的工具。 本文概述了一种行业观点,就是如何最大限度地提高实施有针对性的、常规的审计追踪审核(audit trail review, ATR)的价值。提供了基于风险的ATR的建议,以及何时使用可视化技术和...
临床试验数据的稽查轨迹(Audit Trail),从第一次的数据录入以及每一次的更改、删除或增加,都必须保留在临床试验数据库系统中。稽查轨迹应包括更改的日期、时间、更改人、更改原因、更改前数据值、更改后数据值。此稽查轨迹为系统保护,不允许任何人为的修改和编辑。稽查轨迹记录应存档并可查询。 3.数据管理系统的权限管...
Answer: Yes, but it needs to be described in the SOP. 8. Question: Process verification data is type 3 data --- therefore, there is no need for audit trail review. But is it necessary to review the generation of verification measurement data? Answer: You are right, the key category of...
VMware monitors, review, and audit third party service delivery to ensure alignment with agreed level of information security and service delivery in line with the third party agreement. Based on risk and business impact, changes to the provision of services by the third party ...
Oracle数据库审计(Audit)用于监视用户所执行的数据库操作,如果未配置audit_trail参数,数据库不会监视任何用户的任何操作,会给数据库安全管理留下隐患。 A、 正确 B、 错误 免费查看参考答案及解析 题目: 桌面管理系统中审计账户(audit)审计的内容包括 A、 管理员登录的时间、IP地址 B、 管理员修改、下发、启...
Thus, the saved audit results provide the company officer with a well-documented decision trail demonstrating their good faith in certifying the audit results. In a further embodiment, the audit system includes a system for creating, deploying, and analyzing surveys to perform risk assessment. As ...