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...
内容提示: AUDIT TRAIL REVIEW Standard Operating Procedure – IT, CSV, AND QA TEMPLATE Page 1 / 26 Information Classification: General Many organizations within the pharmaceutical, biopharmaceutical, medical devices, and vaccine industries have procedures, work instructions, job aids or other methods ...
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...
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...
data acquisition, audit trail review, versioning data, data retention, data availability, data retrieval, regulations, data security, third party instrument control, multi- vendor control Summary Audit Trails are an important regulatory requirement and are a proven effective means of detecting data integ...
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...
REVIEW 回顾 Audit Actions Audit Tools Audit Glossary Audit Procedure Audit Directive Audit Findings (Regulatory) Audit Findings (Internal Audits) Examinations Conclusions 审计活动 审计工具 审计术语 审计程序 审计指令 审计结果(药监) 审计结果(内部) 考察与结论 * Big Picture Target the impact Audit trail ...
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 ...
下面根据我的经验给大家几点建议。1.尽量理解上一年经过review了的paper“站在巨人的肩膀上我们会看得更远”,搭paper的架子也一样。既然去年的workingpaper已经完成并得到审阅,在客户整体业务,项目的engagementpartner和manager的要求没有大的变化的情况下我们为什么不...
A trail of documentation showing CPR compliance is a good discipline. Make sure your documentation includes conflict of interest declarations (i.e. showing everyone turned their mind to whether they had a conflict for this particular procurement) and confidentiality agreements from those...