Bio-Rad ProteinChip Qualification and Calibration Kits - Manual (Page 4)

Chapter 1
Introduction
Qualification of analytical instruments is a formal process of documenting that an instrument is
fit for its intended use and that it is maintained and calibrated.
• Installation qualification (IQ) checks that the correct system or instrument was received and
that it was properly installed. IQ is performed by a Bio-Rad service engineer following
installation of the ProteinChip
® SELDI system. The engineer will provide an IQ certificate
upon completion (see Appendix A for an example of this certificate. If you do not have a
copy of this certificate, contact technical support). IQ should also be performed by a service
engineer when the ProteinChip SELDI system is moved to a new location and when the
software is upgraded.
• Operational qualification (OQ) demonstrates that the ProteinChip SELDI system operates in
accordance with Bio-Rad’s requirements. The ProteinChip SELDI OQ kit is used to qualify
the installation and operation of the ProteinChip SELDI system, Personal or Enterprise
Edition. Bio-Rad recommends that the OQ protocols be performed in total upon installation
(following IQ), on a regular basis to confirm that the system is performing to specifications,
and whenever it is suspected that the instrument is not performing to specifications.
For audit review, maintain records of IQ and OQ of the ProteinChip SELDI system in a single
notebook or folder.
1.1 Product and Protocol Description
The ProteinChip OQ kit contains all the ProteinChip arrays and instrument protocols required to
perform OQ on a ProteinChip SELDI system, Personal or Enterprise Edition. The kit is designed
to qualify the operating specifications of the ProteinChip instrument and is a valuable tool that
allows discrimination between assay and instrumentation problems.
The components of each ProteinChip OQ kit support maintenance and testing for a three month
period. Each kit contains the following:
1 CD containing the OQ instrument protocols and the ProteinChip SELDI OQ form
2 ProteinChip detector calibration arrays
6 ProteinChip detector qualification arrays
2 ProteinChip peptide standard arrays
1 ProteinChip OQ kit instruction manual
The OQ protocol involves two maintenance procedures (detector calibration and high voltage
conditioning) followed by a series of four tests of instrument resolution, mass accuracy and drift,
and sensitivity (Table 1).
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