Section 1 introduction, 1 system description 1.2 packing list verification – Bio-Rad Experion DNA Analysis Kits User Manual
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Section 1
Introduction
Qualification of analytical instruments is a formal process of documenting that an instrument is fit
for its intended use and that it is kept maintained and calibrated. The Experion IQ/OQ kit is used
to qualify the installation and operation of the Experion automated electrophoresis station and
software. As a part of the system setup and check, a number of tables are completed and printed.
A completed IQ/OQ test report consists of: 1) cover protocol acceptance page with a list of
appended test reports; 2) the completed test documents; 3) printed test reports. All documentation
should be signed and filed in a notebook for audit review. Such documentation provides a valuable
tool that allows the user to discriminate between assay and instrument problems.
Fig. 1. The Experion system includes the following components: (1) automated electrophoresis
station, (2) priming station (3) vortex station for nucleic acid analysis (4) system operation and data
analysis software and (5) analysis kits (sold separately), which include the (a) chips and (b) reagents
for protein, standard sensitivity RNA, high sensitivity RNA analysis, DNA 1K and 12K.
1.1 System Description
The Experion automated electrophoresis system consists of an electrophoresis station, a priming
station, an optional vortex station (when used with the RNA electrophoresis kits), and software for
data acquisition and analysis (Figure 1).
1.2 Packing List Verification
The Experion automated electrophoresis system is shipped in multiple boxes. The number of
boxes will vary depending upon the catalog number ordered. Refer to the packing list (Section 1.3)
to ensure receipt of all components.
Upon receipt of the complete system and accessories, verify that all boxes and parts are
present by filling out Table I. Record the serial numbers of the components, and the information for
the computer that will operate the instrument, in Table II. (See Section 6)
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5b
5a