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...
USA FDA GLP 483警告信--audit_trail_review 文档格式: .pdf 文档大小: 3.12M 文档页数: 19页 顶/踩数: 0/0 收藏人数: 1 评论次数: 0 文档热度: 文档分类: 待分类 文档标签: USAFDAGLP483警告信--audit_trail_review USA FDA GLP 483警告信--audit_trail_review,USA FDA GLP 483警告信--audit_trai...
审计追踪审核（ATR）作为确保数据完整性的关键工具，已成为行业内的共识。本篇论文由eClinical Forum和SCDM合作撰写，旨在提供实现对大型审计追踪数据集进行针对性例行审核价值的行业观点。文章提出了基于风险的ATR用例建议和相应的报告标准，以及关于何时使用可视化和异常报告生成关键、可操作见解的建议。此外，...
临床研究领域正以快速的步伐发展,特别是随着适应性设计、eSource解决方案的引入以及各种新的数据采集方法的兴起,确保数据的完整性与可靠性变得尤为重要。审计追踪审核 (ATR) 作为确保数据完整性的关键工具,在这个过程中扮演着核心角色。本文旨在概述如何最大限度地实现对审计追踪数据集的有针对性的例行审核,为ATR的基于...
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 ...
Todays new MS PPT slides just posted to the site is from a talk I did in 2020 at the UKOUG. This is a talkDesigning a good database audit trailand a link to it is also posted to ourOracle Security white papers page. This talk focuses on the need to have a useful and well design...
aan audit trail of site inspections,surveys and mitigation reports,photos,and site survey drawing,are all available for review within Cambio,allowing access to the information from any site with an internet connection. 场所检查,勘测和缓和报告,相片和勘址图画查帐索引,是全部可利用为回顾在Cambio之内,允...
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SMART AUDIT TRAIL REVIEW WORKFLOWDisclosed herein are scientific instrument support systems, as well as related methods, computing devices, and computer-readable media. For example, in some embodiments, a scientific instrument support apparatus includes a first logic to obtain chromatography data from ...