ProteOn XPR36, User Manual

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ProteOn XPR36 System | Security Edition
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File Security and Validation
The files used by ProteOn Manager software, Security Edition cannot be
opened or edited using other programs. The software checks the integrity and
validity of a file each time the file opens. If a file becomes damaged or shows
signs of being tampered with by an outside application, it will not open in
ProteOn Manager software.
I
MPORTING
/E
XPORTING
S
ECURE
F
ILES
When you move secure files from one secure system to another secure
system, ProteOn Manager software validates the files to ensure that they have
not been damaged or changed. If such a file has been changed in any way, an
error message notifies you that the file has failed an integrity check; the file
cannot be opened in ProteOn Manager software, Secure Edition.
ProteOn Manager Software Logs
Logs provide a permanent chronological record of all Installation Qualification/
Operation Qualification (IQ/OQ), software, and instrument events. You can
view, copy, export, and print the data from these logs. They are available on
the Instrument screen Log tab in ProteOn Manager software.
Note: Each event in a log includes the name and access level of
the user who performed or authorized the action. If the
application is in Standard mode, the event is flagged as having
occurred outside Secure mode, and the access level is labeled as
“unrestricted.”
Logs are stored in the ProteOn Manager software database.
Secure Documents
ProteOn Manager software, Security Edition supports the creation and control
of secure “electronic records,” as defined by 21 CFR Part 11. It supports the
creation of four types of secure documents:
• Secure experiments
• Processed data
• Analysis results
• Report Point data
Once created and signed, these files are controlled documents, and all
changes are tracked by the software as part of an audit trail. These records
are accessible only through ProteOn Manager software and its associated
utilities.