ChemoMetec NC-250 - Manual (Page 42)

991-0252 Rev. 1.1 February 2013 42
21 CFR Part 11
The U.S. Food and Drug Administration has defined regulations for electronic records and electronics
signatures in Part 11 of Code of Federal Regulations Title 21, in short here termed 21 CFR Part 11.
The NucleoView™ NC-250™ application can be set into a restricted mode, so the user via the NucleoView™
NC-250™ application itself can not violate the 21 CFR Part 11 regulations. This means that on a computer
system that is 21 CFR Part 11 compatible, it is possible to keep the compliancy even after installation and
use of the NucleoView™ NC-250™ application.
Using the 21 CFR Part 11 requires a specific license.
Requirements on the Microsoft Windows Computer System
It is not within the scope of this document to describe in details how to make the computer system, on
which the NucleoView™ NC-250™ application is running, 21 CFR Part 11 compatible. Normally this can be
done by installing and configuring third party software on the computer system.
Apart from installing and configuring a third
party software application on the computer, and activating the
21 CFR Part 11 mode in the NucleoView™ NC-250™ application, the following setup is needed by the
NucleoView™ NC-250™ application itself:
1. Three types of groups need to be defined (either locally on the computer or in the domain the user
logs on to). The groups must be named NucleoViewAdmin, NucleoViewSuperVisor and
NucleoViewUser. Any user logging on to the computer system and using the NucleoView™ NC-250™
application must be part of one of those groups.
2. All users using the NucleoView™ NC-250™ application also need the security policy Impersonate a
client after authentication enabled. It is recommended to enable the Impersonate a client after
authentication for the three groups NucleoViewAdmin, NucleoViewSuperVisor and
NucleoViewUser.
3. A default printer must be defined for each user on the computer as the user can not select nor
change printer destination. And this default printer must not print to a file; it must be a real printer.
Ask the local IT department for how to setup the above three listed items.
NucleoView™ User Groups
Any user logged onto the computer and starting the NucleoView™ NC-250™ application must be member
of one of the groups NucleoViewAdmin, NucleoViewSuperVisor and NucleoViewUser.
The NucleoView Admin user have full rights in the NucleoView™ NC-250™ 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 general rights in the NucleoView™