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...
Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record (e.g., §§ 211.22(a), 211.101(...
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。
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...
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。
LCquan 是符合 FDA21CFR Part11 要求的软件,具有自动审计追踪(Audit Trail)功能,界面简单易用,满足制药行业法规的电子签名和电子信息记录要求。 一、专属的Audit Trail数据库 LCquan Audit Trail 是以 Microsoft Access 数据库的方式进行储存,在建立项目工作目录(Workbook)后,会在该 Workbook 根目录下自动生成相应的...
Provides an audit trail.(FDA Compliance)
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...
For example, a label audit trail could tell you that Darryl requested a new label template for a new line of pre-made salads. You could then see that Judith created the first draft of the label and sent it to Sam for review. Sam sent back edit requests to include proper allergen labeli...
or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copyingSupportsCentralized collec...