Biotek Synergy LX, User Manual

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IQ/OQ/PQ Description | 87
Operational Qualification confirms that the equipment operates according to specification
initially and over time.
l
The recommended OQ procedure consists of performing the system test and a
series of tests for the absorbance, fluorescence, and luminescence systems, as
applicable for your instrument model.
l
The OQ procedure should be performed initially (before first use) and then
routinely; the recommended interval is annually. It should also be performed after
any major repair or upgrade to the hardware or software.
l
Although out-of-tolerance failures will be detected by the OQ tests, results should
be compared with those from the routine Performance Qualification tests and
previous OQ tests to monitor for trends.
l
The successful completion of the OQ procedure, in combination with results that
are comparable to previous PQ and OQ tests, confirms that the equipment is
operating according to specification initially and over time.
Performance Qualification confirms that the reader consistently meets the requirements
of the tests performed at your laboratory.
l
The recommended PQ procedure consists of performing the system test and a
series of tests for the absorbance, fluorescence, and luminescence systems, as
applicable for your instrument model.
l
Your facility’s operating policies may also require that you routinely perform an
actual assay to confirm that the reader will consistently give adequate results for
the assays to be run on it.
l
These tests should be performed routinely; the recommended interval is monthly
or quarterly, depending on the test. This frequency may be adjusted depending on
the trends observed over time.
l
The successful completion of the PQ procedure confirms that the equipment is
performing consistently under normal operating conditions.
Synergy LX User Manual
1501000N Revision A BioTek Instruments, Inc.