Biotek Synergy H1, Operator'S Manual

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IQ/OQ/PQ Description
Installation Qualification confirms that the reader and its components have been
supplied as ordered and ensures that they are assembled and configured properly for your
lab environment.
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The recommended IQ procedure consists of setting up the instrument and its
components as described in the Installation chapter, and performing the System
Test. For models with injectors, a quick test with fluid is also performed, to ensure
that the dispense module is properly installed and there are no leaks.
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The IQ procedure should be performed before the reader is used for the first time.
The successful completion of the IQ procedure verifies that the instrument is
installed correctly.
Operational Qualification confirms that the equipment operates according to
specification initially and over time.
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The recommended OQ procedure consists of performing the System Test,
Absorbance Plate Test, a series of Fluorescence Tests, and, if the external dispense
module is used, Dispense Accuracy and Precision Tests.
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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.
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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.
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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.
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The recommended PQ procedure consists of performing the System Test, Absorbance
Plate Test, a series of Fluorescence Tests, and, if the external dispense module is
used, Dispense Accuracy and Precision Tests. 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.
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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.
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The successful completion of the PQ procedure confirms that the equipment is
performing consistently under normal operating conditions.
Synergy H1 Operator's Manual
IQ/OQ/PQ Description | 109