Biotek MicroFlo select - IQ;OQ;PQ

70 | Instrument Qualification
BioTek Instruments, Inc.
IQ/OQ/PQ
Installation Qualification (IQ) confirms that the dispenser and its components have
been supplied as ordered and ensures that they are assembled and configured properly for
your lab environment.
 The recommended IQ procedure consists of setting up the instrument as
described in
Chapter 2, Installation and then performing the System Self-
Check and the Checksum Test.
 The IQ procedure should be performed initially (before the dispenser is used
for the first time).
 The successful completion of the IQ procedure verifies that the instrument is
installed correctly. The Operational Qualification procedure (see below) should
be performed immediately following the successful IQ.
Operational Qualification (OQ)
confirms that the dispenser operates according to
specification initially and over time.
 The recommended OQ procedure consists of performing the System Self-
Check, the Checksum Test, and the appropriate Dispense Precision and
Accuracy Tests.
 Your facility’s operating policies may also require that you perform an actual
assay prior to accepting the dispenser for routine use. You should not use the
data obtained from the first assay that utilizes the dispenser until you have
confirmed that the package insert criteria have been met.
 The OQ procedure should be performed before first use and then 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 monthly 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 dispenser is
performing consistently over time.