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8 D39051 | Date 12/2019 | v2.9 AtmoCONTROL FDA Edition – IQ-OQ-Documentation 3. Operational Quali fi cation Operational Qualification (OQ) demonstrates that the AtmoCONTROL FDA software is func- tioning to specification. …
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AtmoCONTROL FDA Edition – IQ-OQ-Documentation
Was the software installed successfully?
yes no
2.3 Assessment of Installation Qualifi cation
The installation qualification has been passed successfully if all previous questions have been
answered with yes. If not, the errors have to be fixed and the installation qualification needs
to be repeated.
I hereby confirm that all previous questions have been answered with YES.
Name Position Date Signature
8 D39051 | Date 12/2019 | v2.9
AtmoCONTROL FDA Edition – IQ-OQ-Documentation
3. Operational Qualifi cation
Operational Qualification (OQ) demonstrates that the AtmoCONTROL FDA software is func-
tioning to specification. Operational Qualification tests should be performed:
► Once upon receipt of the instrument
► When the computer or software that runs the instrument is changed or modified
Software IQ tests should be performed prior to the OQ tests in order to verify that the soft-
ware is installed properly.
3.1 Login
Start the AtmoCONTROL FDA Version by double-clicking the appropriate icon or in the start
menu.
Does the Login window appear after starting AtmoCONTROL FDA?
yes no
If the username and/or password are incorrect, does the login fail?
yes no
Can you login with your user name which was created during Setup?
yes no
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AtmoCONTROL FDA Edition – IQ-OQ-Documentation
After login, does the program start with the AtmoCONTROL window?
yes no
Is Admin displayed in the title bar?
yes no
3.2 Admin and User Rights
Is the menu item Security available?
yes no
Does the following window appear after clicking Edit users in the
Security menu?
yes no