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D39051 | Date 12/2019 | v2.9 7 AtmoCONTROL FDA Edition – IQ-OQ-Documentation Was the software installed successfully? yes no 2.3 Assessment of Installation Quali fi cation The installation qualification has been passe…
6 D39051 | Date 12/2019 | v2.9
AtmoCONTROL FDA Edition – IQ-OQ-Documentation
2.1 Packing List Verifi cation
Operating software “AtmoCONTROL FDA Version“on USB stick in-
cluded?
yes no
Operating instructions for “AtmoCONTROL FDA Version“on USB stick
included ?
yes no
Is the AtmoCONTROL FDA Version Software USB stick undamaged?
yes no
No externally visible damage to the USB stick or packaging material?
yes no
Delivery complete according to order and order confirmation (e.g.
Software and Installation Manual)
yes no
The answer to all questions must be “yes“ in order to move on to the next qualification stage,
otherwise rectify the fault!
2.2 Software Installation (to be completed by user)
Are the following requirements fulfilled?
► Computer is running operating system Windows 7, Windows 8,
Windows 10?
► Enough internal memory is available for a successful installation (at
least 1GB)?
► Installer has administrator rights?
yes no
For the installation process please refer to the AtmoCONTROL User Manual and follow the
instructions under Section “Installing AtmoCONTROL.” The manual was delivered along with
the AtmoCONTROL FDA Version Software USB stick.
Installation
During installation, are you prompted to create an “Admin” account
with a password?
yes no
D39051 | Date 12/2019 | v2.9 7
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