Audit trails are considered part of the associated records. Personnel responsible for record review under CGMP should review the audit trails that capture changes to critical data associated with the record as they review the rest of the record (for example, §§ 211.22(a), 211.101(c), 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). This is similar to the expectation that cross-outs on paper be assessed when reviewing data.
