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(c) and (d), 211.103, 211.182, 211.186(a), 211.192, 211.194(a)(8), and 212.20(d)). For example, all production and control records, which includes audit trails, must be reviewed and approved by the quality unit (§ 211.192). The regulations provide flexibility to have some activities reviewed by a person directly supervising or checking information (e.g., § 211.188). FDA recommends a quality system approach to implementing oversight and review of CGMP records.12

审计追踪类似于在审核数据时评估纸质版上面的划线删除。负责记录审核的人员应审核审计追踪以捕捉与记录相关的数据更改(e.g., §§ 211.22(a), 211.101(c) and (d), 211.103, 211.182, 211.186(a), 211.192, 211.194(a)(8), and 212.20(d))。例如, 所有生产和控制记录, 包括审计跟踪, 都必须由质量部门审核和批准 (第211.192 节)。法规提供了灵活性，可以由直接监督或检查信息的人员来审核某些活动（例如，§211.188）。 FDA建议采用质量体系方法来实施对CGMP记录的监督和审查。