审计追踪审核的法规要求

恨我不成钢

Since 2011, Annex 11"Computerised Systems" of the EU GMP Guideline has demanded records of all GMP relevant changes and deletions to be implemented as a system-integrated Audit Trail: the reasons for changes and deletions must be documented. Audit Trails must be available, convertible into a generallyreadable form and checked regularly.

自2011年，EU GMP指南附录11《计算机化系统》要求所有GMP相关的修改和删除应记录作为系统完整性的审计追踪：应记录修改和删除的理由。审计追踪应被激活，并转换成一般可读的形式，以及进行定期检查。

The PIC/S draft "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments"from August 2016 also defines Audit Trails and provides comprehensive review requirements.

PIC/S草案“受法规约束的GMP/GDP环境下数据管理和完整性良好规范”自2016年8月也定义了审计追踪，并提供了全面的审核要求。

Pharmaceutical companies should upgrade their software so that the functionality for Audit Trails is included. Through this, all events in the system can be recorded and all activities regarding the collection,evaluation, deletion and overwriting of data for the Audit Trail Review are made available.

制药企业应升级其软件以包括审计追踪功能。如此，系统中的所有事件都可以被记录，所有数据采集、评估、删除和重写活动都可以进行审计追踪。

Audit Trails should be part of the system validation. The validation documentation is to show that the Audit Trails are functional and that all activities, changes and other transactions are recorded in a useable form.

审计追踪应该是系统验证的一部分。验证文件应证明审计追踪具备其功能，以及证明所有的活动、修改和其它事务均得到有效记录。

It is also required that Audit Trails are reviewed regularly. For this purpose, every company has to implement a standardoperating procedure (SOP), in which the strategy and the procedure for theAudit Trail Review are determined in compliance with risk management principles. This also applies to "ongoing reviews" of Audit Trails depending on the criticality and complexity of the system.

另外还需要定期对审计追踪进行审核。为此，每个公司都应有标准操作规程（SOP）。在该SOP中要依据风险管理原则确定审计追踪审核的策略和程序。这也适用于依据系统关键程度和复杂程度所执行的审计追踪“持续审核”。

If significant deviations are found during the Audit Trail Review, these must be fully investigated and documented. The procedure of the measures a company takes in such a case in order to ensure the quality of the produced drug product must also be described in an internal SOP.

如果在审计追踪审核过程中发现重大偏差，则必须进行全面调查并记录。公司在此情形下为了确保所生产药品质量而采取的措施还必须在SOP中描述。

Moreover, the FDA has also defined the term Audit Trail intheir "DataIntegrity Guidance for Industry" draft from April 2016: an AuditTrail is a chronology of the "who, what, when and why" for a specificdata record. As an example, the Audit Trail of a HPLC system is named. The HPLCAudit Trail should include: the user, date and time of the run, the integrationparameters used and, when applicable, further details on reprocessing,including the justification for the reprocessing.

另外，FDA也在其“2016年4月行业数据完整性指南草案”中定义了术语审计追踪：审计追踪是对特定数据记录“何人何事何时为何”内容的时序记录。例如，HPLC系统的审计追踪被列了出来。HPLC审计追踪应包括：用户、运行时间和日期、所用积分参数以及（适用时）重新处理的更多细节，包括重新处理的论证。

syhorchid

了解一下

大海

关注一下，学习学习

ielisa

请教各位大神，想了解哪些内容是需要被记录到审计追踪里面的，这个需要溯源到哪部指南或者规范？