Performing the
Performance Qualification:
Perform the
Operational Qualification as per the check list which contains points defined
in the installation requirement that the Crystal Panel Viewer is supposed to fulfill. In addition, list
out control points installed and check the temperature and humidity conditions
achieved after the Crystal Panel Viewer has been started after shut down. Note
down all the observations in the Operational Qualification Report. Crystal
Panel Viewer shall be handed over to Quality Control only after successful
completion of Operational Qualification.
Record all observations and deviations in the
report. In case of deviation prepare a deviation report with justification and
get it approved by Head Quality assurance, Head Quality Control.
Check list For
Performance Qualification
EQUIPMENT /
SYSTEM: CRYSTAL PANEL VIEWER
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Test ( S)
Required
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Test Description
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Acceptance Criteria
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Results
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Checked
by
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To check whether the panel is getting on / or
not.
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Connect the A/c supply to the instrument, switch on
the button and observe the panel.
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The external white light should be illuminating the lower panel &
U.V. light should illuminate the upper chamber.
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To check whether the distinguishing fluorescence
is observed or not.
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Carry out the procedure for any Gram positive
organism. And observe same under UV.
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It should show clear distinguishing fluorescence
which should be compared with the standard chart.
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To check whether identification kit is
identifying the organism properly or not.
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Carry out the test by using suspension of a known
standard organism, and observe the result and compare it with the
software.
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The identification kit should identify the known
organism with high % of identification.
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