For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. For example, the audit trail for a high performance liquid chromatography (HPLC) run should include the user name, date/time of the run, the integration parameters used, and details of a reprocessing, if any. Documentation should include change justification for the reprocessing.

就本指南而言，审计追踪是指安全的、计算机生成的、带时间戳的电子记录，允许重建与电子记录创建、修改或删除相关的事件过程。例如，高效液相色谱（HPLC）运行的审计追踪应包括用户名、运行日期/时间、使用的积分参数，以及再处理（如有）的详细信息，包括再处理的变更理由。

Audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).

电子审计追踪包括那些对数据（例如处理参数和结果）创建、修改或删除的跟踪以及那些在记录和系统层面的跟踪行动（例如试图访问系统或重命名或删除文件）。

CGMP-compliant record-keeping practices prevent data from being lost or obscured and ensure that activities are documented at the time of performance (see §§ 211.68, 211.100, 211.160(a), 211.188, and 211.194). Electronic record-keeping systems, which include audit trails, can support these CGMP requirements.

符合CGMP的记录保存做法防止数据丢失或模糊，并确保在执行活动时记录（见§§ 211.160(a), 211.194, and212.110(b)）。电子记录保存系统，其中包括审计追踪，能够满足这些CGMP要求。