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Astell Autoclaves/Sterilisers – AMB220 | AMB230 | AMB240 | AMB420 | AMB430 | AMB440 | AMA240 | AMA440
USING CFR USER LOGGING AND AUDIT
FUNCTIONS
In addition to the standard Astell autoclave control
system. There is now the ability to electronically record
the following actions to assist with 21 CFR 11 compliance.
1. All setpoint and machine configuration changes are
audited with user and date/time stamp.
2. Any changes to the machine configuration are audited
with user and date/time stamp.
3. Any changes to the Cycle Type files are audited with
user and date/time stamp.
4. Any changes to the Customer Cycle files are audited
with user and date/time stamp.
5. Cycle log files are protected to ensure they cannot by
modifed.
6. All operator interactions are audited.
Initial preparations
The following information is intended for the person
responsible for the administration of the users of the
equipment and the maintenance of electronic records
generated by the equipment.
Log in as Administrator:
From the main screen, press
and then
Login as ‘Admin’ with the password ‘555555’
This User is preset to give administrator access. (This can
be changed to suit after initial set up).
Initial Set up
To enter the screen shown below, press the ‘spanner icon’
at the top of the screen.
Set the Time, Date, Language and screen preferences.
Press the “BACK” button to display the ‘User Login’
screen.
To add Users
To set up new users, you will have to be logged in as
Admin, or other user, with administrator rights.
Press the “USER SETTINGS” button to show the ‘User
Manager’ screen , shown below.
By pressing the
button. The next screen will
allow you to set up a new users details.