Biotek Synergy HT, Руководство оператора

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IQ/OQ/PQ
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Synergy HT Operator's Manual
Operational Qualification confirms that the equipment operates according to
specification initially and over time.
•
The recommended OQ procedure consists of performing the System Test,
Absorbance Plate Test, a series of Liquid Tests, and, if the external dispense
module is used, the Dispense Accuracy and Precision Tests.
•
Your facility’s operating policies may also require that you perform an actual assay
prior to accepting the reader for routine use. If this is the case, you should not use
the data obtained from the first assay run on the reader until you have confirmed
that the package insert criteria have been met.
•
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.
•
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.
•
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.
•
The recommended PQ procedure consists of performing the System Test,
Absorbance Plate Test, a series of Liquid Tests, and, if the external dispense
module is used, the 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.
•
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.
•
The successful completion of the PQ procedure confirms that the equipment is
performing consistently under normal operating conditions.