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6 D39051 | Date 12/2019 | v2.9 AtmoCONTROL FDA Edition – IQ-OQ-Documentation 2.1 Packing List V eri fi cation Operating software “ AtmoCONTROL FDA V ersion“on USB stick in- cluded? yes no Operating instructions for “ …
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1. Introduction
The task of the FDA is the protection of public health in the US and the approval of pharma-
ceutical products. The FDA controls the safety and efficacy of medical products for human
and veterinary medicine, biological products, medical devices, food and radiation - emitting
devices, that arrive in the American market. This applies to products manufactured in the US
as well as imported products. FDA plays a significant role in addressing the Nation’s counter-
terrorism capability and ensuring the security of the food supply.
The Electronic Records and Signatures Rule, known as 21 CFR Part 11, were introduced by
the U.S. Food and Drug Administration (FDA) in order to define requirements for the use of
electronic documents instead of paper records. The law, published in the Federal Register on
March 20, 1997 and in effect since August 20, 1997, specifies the system elements, controls,
and procedures that are necessary to make sure the trustworthiness of electronically stored
records.
Conformity requires both procedural controls and administrative controls, such as Standard
Operating Procedures (SOPs), training and administration to be put in place by the user, in ad-
dition to the technical controls and elements that the system can offer. Therefore, no product
alone can fully meet the regulatory requirements. However, products with unified functions
that support 21 CFR Part 11 requirements can significantly ease the task of achieving and
maintaining full conformity with the law.
1.1 Purpose of Qualifi cation
Qualification of instruments or software is a formal process of documenting that an instru-
ment or software is fit for its intended use and that is kept maintained and calibrated.
IQ: The purpose of this qualification is to examine that the product designated as “examina-
tion object“ is complete and is essentially ready for operation.
It also documents that all important specifications and parameters described by the manufac-
turer, as well as its safety requirements, are fulfilled.
OQ: The purpose of this qualification is to ensure the function of the product designated as
“examination objects” and that it is ready for operation.
The following functions are tested:
► Security functions (according to FDA Titel 21 CFR Part 11)
► Control functions relevant for quality and/or process
2. Installation Qualifi cation
Installation Qualification (IQ) demonstrates that the AtmoCONTROL FDA software is properly
installed. Installation Qualification tests should be performed at the following times:
► When the system is installed
► Every time the software is upgraded
► Any time the associated computer is changed or modified
► Prior to running OQ tests
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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
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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