In their 2016 data integrity guidance, the FDA requires that audit trails be reviewed in their entirety. This extremely daunting task can be made simple by using Ofni Systems’ audit trail summary report.
A copy of the audit trail generated by ExcelSafe can be exported to any spreadsheet for review. The exported audit trail is then organized for review using Ofni Systems’ audit trail summary report within the spreadsheet. The audit trail summary report displays key summary statistics of the spreadsheet audit trail including:
The audit trail summary report also allows users to filter the audit trail based on key audit trail metadata for easy review.