PCI/CFR Overview > CFR Features

CFR Features

PCI/CFR helps you to store your image data in a manner that complies with the FDA's 21 CFR Part 11 regulations.

It does this by providing the following features:

the user is required to authenticate when starting the software.
authentication events are recorded in the Windows Application Event Log, allowing you to track who used the system when and to track invalid log-in attempts.
A workstation log is maintained that logs user sessions and tracks image acquistion and access to images, whether or not the user saves or re-saves the image.
users can be given different roles by assigning them to Windows groups.
the original digital image generated by the instrument is stored before any image manipulation functions are executed by the user and can be exported in its original format.
an audit trail is maintained of all operations carried out on the image by the user within the PCI/CFR software.
images can be digitally signed using two distinct identification components.
all versions of image files are retained by the system. If the user saves a new version of an image, it is assigned a version number in sequence and does not overwrite the original data.
you can choose to lock down the locations to which images can be saved or exported and from which they can be loaded.
data files are encrypted to discourage tampering and are protected using a "digest" to detect tampering.
digitally signed PDF files may be exported.

In addition, a Secure Repository option is available that allows you to track documents created by third-party applications and to track changes to images made in third-party applications.