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Audit Trail

A robust auditing system is a critical component of clinical trials software. According to the FDA Title 21 CFR Part 11, a full audit trail must begin as soon as the information hits the durable media. Entrypoint i4 provides an auditing system in conformance with the Part 11 requirements: the Entrypoint Audit Trail Facility (ATF) tracks all changes made to records from the time they are first entered into the case report form throughout all editing activity, regardless of the number of users working on them.


The Entrypoint Audit Trail Facility can be configured so that the user is required to give explanations for changes in specified fields: an audit comment window displays as soon as the user finishes changing the field.

ATF Comment Dialog Box


You can view or print Entrypoint Audit Trail reports at any time; these reports are always available for agency review. Audit reports can be produced for a specified batch, operator, format, field, entry mode (add, modify, etc.) or date range.

View an example report in PDF format.