ChemoMetec NC-200 - Manual (Page 41)

991-0204 Rev. 1.1 September 2012 41
The NucleoView Admin user have full rights in the NucleoView® NC-200™ application, e.g. the user may
switch 21 CFR Part 11 mode on or off, thus breaking the 21 CFR Part 11 compliance.
The NucleoViewSuperVisor and NucleoViewUser users have the same rights in the NucleoView® NC-200™
application, and are restricted in their use of the application. Running the NucleoView® NC-200™
application as one of those users makes it impossible to break the 21 CFR Part 11 compliance.
Apart from securing the user can not tamper with measured results in the NucleoView® NC-200™
application in 21 CFR Part 11 mode, all operations changing the behavior of the NucleoView® NC-200™
application, all new files created etc. are logged in the event log system. The user needs to be part of the
NucleoViewAdmin group to see the event log.
The event logs created by the NucleoView® NC-200™ application are always stored in the current results
folder. Changing this folder will create a new event log file in the newly set results folder.
It is recommended to backup the event logs, archived and aged according to the same rules as e.g. the
results created by the NucleoView® NC-200™ application itself. See Maintenance and Backup for details.
Event Log
The event log system of the NucleoView® NC-200™ records all operations made by the user. The
NucleoViewAdmin user can launch the event log viewer via the main menu View -> Event Logs. This will
bring up the window shown below:
To the left is shown a list of existing event log files, one for each month. Selecting one of these will bring up
the content of this event log file to be shown in the right window. Clicking on one of the headers in the
right window will sort the content according to the selected column either ascending or descending.
Note that in the date column, some of the entries have a small * marked. This indicates that the
NucleoView® NC-200™ application has recorded this event happened when the application was not in 21
CFR Part 11 mode.