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...
随着数据量的不断增长,尤其是在EDC之外收集的数据量超过在eCRF上收集的数据量,并且每年都在以更快的速度增长的情况下,数据完整性的重要性日益凸显。监管机构,如MHRA、FDA、EMA、PMDA,强调了常规电子ATR在确保数据完整性方面的作用。在ICH-GCP的更新中,对审计追踪的要求和监管也相应提高。随着EDC、eCOA、可穿戴设备...
并使用各种技术来收集、处理和报告数据。全球监管机构，如FDA、EMA和PMDA，都已注意到EDC、eCOA、ePRO、eConsent和数字健康工具等方法的发展。面对不断增长的市场和行业对技术的采用，制药公司越来越多地依赖第三方服务供应商提供这些技术。
稽查轨迹(Audit Trail):是计算机系统(如数据管理系统)的基本功能。是指系统采用安全的和计算机产生的带有时间烙印的电子记录,以便能够独立追溯系统用户输入、修改或删除每一条电子数据记录的日期、时间以及修改原因,以便日后数据的重现。任何记录的改变都不会使过去的记录被掩盖或消失。只要受试者的电子记录保存不变。 ...
audit trail Informatics A software-tracking system used for data security, which is attached to a file each time it is opened so an operator can identify who and when a file has been accessed. Medspeak-UK (1) A sequential printed or electronic record of individual audits, which can be use...
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An audit trail is also the term used to describe the document record that traces an accounting action, such the entry of a transaction, from its posted entry in a ledger back to its source in a subledger or as a journal entry in General Ledger. Audit State An audit state indicates the...
审计跟踪(audit trail),是()的流水记录。A.浏览器访问B.系统活动C.ftp 上传下载D.都是的答案是什么.用刷刷题APP,拍照搜索答疑.刷刷题(shuashuati.com)是专业的大学职业搜题找答案,刷题练习的工具.一键将文档转化为在线题库手机刷题,以提高学习效率,是学习的生产力工具
Improved compliance.Comply with industry standards and government regulations while maintaining an accurate, searchable audit trail. Key Considerations for Audit Management Software When you’re evaluating potential audit management solutions for your business, start with detailing all your requirements and cat...
Since the release of the latest FDA guidance documents on 21 CFR part 11 and data integrity, there has been much confusion regarding what is required for c... I Nir - 《American Pharmaceutical Review》 被引量: 0发表: 2022年 21 CFR Part 11 Compliance December 21, 201121 CFR Part 11 Comp...