Unlock files
In SAE mode, signed files are locked and must be unlocked by a user with unlock
privileges before any further changes can be made to the file. When a file is
unlocked, the file’s e-Signature status changes to inactive.
1.
In the Gallery, select the desired image file(s), touch
Actions
and then touch
Unlock
.
Note:
The user will be warned that they are about to inactivate the signature.
Note:
Unlock
is also available under
More Options
in the acquisition, analyze,
and adjust workflows.
2.
The user must comment about why the file is being unlocked, then touch
Unlock
.
• A message informs you when the file has been successfully unlocked.
• e-Signature becomes inactive in the e-Signature history status.
Generate an audit history
1.
Touch
Audit history
to review the audit history and the change table for the
selected image file.
• The audit history contains the following information: Version, Date & Time,
Username, Role, Action, Reason and Comment.
•
Audit history
is also available in the Adjust and Analyze workflows under
More options
.
2.
Select one row in the audit history to view the image and change details for the
selected and previous version, or select any two rows to view the images and
change details for the two selected versions.
3.
Touch
Open
to view and compare the images from selected versions.
4.
(Optional)
Change the channel from the drop-down menu on top of the image to
view a different channel image in a multichannel image.
5.
(Optional)
Select/deselect layer options on the top of image to show/hide the
layers on image.
6.
Touch
Audit Report
to generate the Audit History Report as a pdf file. The
report contains an audit history table along with the image comparisons of the
selected versions.
7.
Touch
Export
to export the Audit History Report to a USB drive, network
drive, or network printer.
Invitrogen
™
iBright
™
SAE Software Solution for 21 CFR Part 11 Support
Unlock files
42
iBright
™
CL750 Imaging System User Guide
