Audit Trail Facility
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 Plus provides an auditing system in conformance with the Part 11 requirements: the Entrypoint Plus 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.
Configuration Choices
The Entrypoint Plus Audit Trail Facility can be activated on an application-by-application basis. It 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.
To standardize responses, the developer can create a set of predefined audit comments for an application. These comments can be defined as fixed (the operator must use one as is) or modifiable (the operator can select the comment and edit it). Comments can also be defined for specific fields or formats.
Audit trail tracking data can be enabled for all users, groups of users, or individual users.
Reporting
You can view or print Entrypoint Plus Audit Trail Facility 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.
The report includes the name of the application, the name of the batch, date the record was entered or changed, operator ID, format name, type of entry, and record position. For each data change, it lists the original and new data—both as displayed in the Workstation and as stored in the database—and any operator comments associated with the change.
Example Report
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