Section 2 installation qualification (iq), 1 software iq 2.2 hardware iq – Bio-Rad Experion DNA Analysis Kits User Manual

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Section 2
Installation Qualification

Installation Qualification (IQ) determines if the Experion automated electrophoresis station and
software are properly installed. Installation Qualification tests should be performed at the
following times:

• When the system is installed
• When the station is moved to a new location
• Every time the software is upgraded
• Any time the associated computer is changed or modified
• Prior to running OQ tests

These tests are accessed through the Experion software and are available to customers who have
purchased the IQ/OQ package.

2.1 Software IQ
It is necessary to install and test the software prior to installation of the Experion
electrophoresis station. The computer system must be setup and minimum operating
requirements must be verified, before the software is installed (refer to Table III in Section 6).
Proper installation of the software is verified by running the automated software IQ test found in
Table V (See Section 6).

Software Installation
Place the Experion electrophoresis station and computer on a bench that is free of
excessive dust, moisture, strong magnetic fields, ionizing radiation and vibrating instrumentation
(i.e., shakers, centrifuges, etc). All equipment should be away from heat sources. It is best to have
a dedicated computer for running and analyzing files from the Experion electrophoresis station.
If a computer cannot be dedicated, and multiple pieces of instrumentation are connected to the
same computer, capability limitations and communication problems may occur. Some systems
require a dedicated computer as they will dominate the USB ports and restrict communication with
other instrumentation. Other systems will require a specific setup sequence before communicating
properly. Compatibility of systems and computers must be determined prior to running the system.
The computer configuration is first confirmed by completing the equipment identification. Then
follow the instructions in Table IV (See Section 6) to install the software.

The software IQ test verifies that all of the Experion software files are installed and properly
configured. The test is accessed through the Experion software and available to customers who
have purchased the IQ/OQ package. Follow the instructions in Table V (See Section 6) to run the
Experion software IQ test.

2.2 Hardware IQ
The hardware IQ describes proper setup of the Experion electrophoresis station. The
hardware IQ procedure ensures that the electrophoresis station is able to be powered up and will
communicate with the software installed on the computer. Follow the instructions in Tables VI and
VII (See Section 6) to perform the hardware IQ setup and test.

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