8 21 cfr part 11 compliance features, 1 21 cfr compliance check box, 2 maximum password age – Metrohm Vision Manual User Manual
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8
21 CFR part 11 compliance features
Important:
This version of Vision software is compliant with 21 CFR Part 11 (electronic records). The new
features that make Vision compliant may make software operation too cumbersome for users who
do not need to be compliant. During software installation a user has to decide whether Vision needs
to be compliant with 21 CFR Part 11 regulations. Choosing non-compliant installation will disable
some of features described later in this chapter.
Those features can be disabled or enabled by the System Manager after Vision is installed. The way
to do it is described later in this chapter.
Please note that the 21 CFR Part 11 compliance are not available in chemical version of Vision.
8.1
Configuration screen for 21 CFR part 11 Enhancements
Only the System Manager has authority to configure 21 CFR part 11 features.
In Data Acquisition mode, click on Configure/Account Policy. This opens the Account Policy
configuration window. This window (shown below) contains a number of check boxes and
fields.
8.1.1
21 CFR Compliance check box
This box toggles the compliance on and off. When the compliance is disabled, the System Manager
has to confirm and sign the change. All changes in the compliance status are logged into Audit Trail.
8.1.2
Maximum Password Age
This configurable list box defines the number of days after which Vision will request password
change.
8.1.3
Password Uniqueness
This configurable list box defines the number of unique passwords that have to be created for a
particular user before an old password can be re-used.