21Cfr11 Environments; Overview - Micromeritics GEMINI VII 2390 Installation Instructions And Checklist

8 21CFR11 E
If using a keypad with the analyzer, skip this chapter.
O
VERVIEW
The Micromeritics Confirm application enables laboratory managers in 21CFR11 environments to
develop analysis methods, enforce industry standards, produce audit trails, and enables
laboratory analysts to perform analyses and produce reports.
When the Confirm application is installed, one Confirm application controller and two Confirm
groups are created in Windows Users and Groups. Refer to
page for specific default rights of members assigned to each Confirm group.
Application User default name:
Developer Group default name
Analyst Group default name
Once an account holder logs in and launches the Confirm application, it is launched using the
application controller's permissions. Analysts and developers must not be allowed access to this
account. After installation, use Windows Users and Groups to create and maintain users. See
Maintaining Confirm Users and Groups on page 8 -
Prior to installing the Confirm application, the following prerequisites must be met:
The Confirm application installer must have Windows Administrator rights.
n
Computer must have an operating system of Windows 10 Professional or Windows 10 Enter-
n
prise or higher.
Configure an Ethernet port on the computer to communicate with the analyzer. The IP address
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must be 192.168.77.100. Refer to the computer operator manual for instructions on changing
the IP address.
Gemini VII 2390 Installation Instructions and Checklist
239-42870-02 Rev (B) — May 2021
NVIRONMENTS
mic_[analyzer model number]_controller
mic_[analyzer model number]_developer
mic_[analyzer model number]_analyst

8 21CFR11 Environments

User Permissions on the next
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