Bio-Rad Experion DNA Analysis Kits - Manual (Page 13)

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Section 3
Operational Qualification
Operational Qualification (OQ) demonstrates that the Experion automated electrophoresis station
and software are functioning to specification. Operational Qualification tests should be
performed:
• Once upon receipt of the instrument
• When the instrument is moved to a new location
• When the computer or software that runs the instrument is changed or modified
Operational Qualification tests should also be run on a regular basis to confirm the system
continues to function to specifications. We recommend performing OQ tests at 3 month intervals,
and when there is a question that the instrument is not performing to specifications. Software
and hardware IQ tests should be performed prior to the OQ tests in order to verify that the
software and hardware are installed properly.
3.1 Software OQ
Software OQ verifies that the calculations used to analyze data files are complete and are
functioning correctly. Calculations are performed on a data file where the results are known. Test
results are compared to the expected results to verify the software is functioning properly. Run the
software OQ as described in Table VIII (See Section 6).
3.2 Hardware OQ
Hardware OQ demonstrates that the electrophoresis station is performing to specifications. Tests
are performed to confirm that the laser and detector are operational. Additional tests demonstrate
that the electrophoretic functions of the instrument are functioning to specifications. Run the
hardware OQ as described in Table IX (See Section 6).
3.3 List of OQ Documents
Protocol Approval and List of Tests Performed
Software OQ
Table VIII: Software OQ Test
Sample Software Results
Hardware OQ
Table IX: Hardware OQ Test
Sample Hardware Results