Reporting for 21 CFR Part 11 - Part 4 Security Features
This segment demonstrates advanced security features that can be enabled in the XLReporter project.
Secure authentication is provided in the form of global user accounts to allow different levels of access to the reporting project.
The audit trail keeps a secure log of user activity in the areas of configuration and design changes.
Version control allows changes to be logged to an encrypted audit trail database that tracks when the change occurred and which user performed the change. A roll back feature is provided to restore the system to a previous setup if the change was incorrect.
Electronic signatures are a means for users to indicate electronically that a report is true and accurate. When the signing process is complete, XLReporter attaches a signature certificate to the report containing the list of signees.