Metrohm NIRS XDS Transmission OptiProbe Analyzer - Manual (Page 81)

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• Serves as Installation Qualification and Operating Qualification for new instrument
installations
Meets CFR 21 requirements for instrument qualification.
• Independent assessment, not performed by instrument user
Meets independent test requirements of CFR 21 and most auditing methods.
• Full documentation of all tests, adjustments and findings
Serves as Instrument Log, with valuable records of ongoing performance.
9.1.5 Metrohm Master Instrument Program
In support of our worldwide base of instruments, Metrohm maintains a Near-Infrared XDS Master
Transmission Instrument. This instrument is calibrated with vaulted standards, using several different
(yet complementary) techniques to assure consistency and accurate response. Full records of testing
and calibration are logged and maintained on an ongoing basis.
By maintaining a Master Instrument, FOSS is able to track long-term response of field instruments,
verify ongoing operational improvements to manufactured systems, and provide yearly re-calibration
of NIRStandards used in Instrument Performance Certification.
This long-term, stable Master Instrument assures our users of consistent measurement methodology
between instruments, and for a given instrument over time.
9.2 Software Validation Tools
9.2.1 Installation and Operating Qualification Documents
Software Installation Qualification (IQ) and Operating Qualification (OQ) Documents are included as
part of the Vision® Spectral Analysis Software package. These documents are presented in checklist
fashion, guiding the user through each step in setting up and qualifying the instrument.
The software OQ is a pre-built project model, using actual spectra. It is imported for quantitative and
qualitative analysis, and output results are calculated. The calculated results are matched with known
results from a validated system, to verify installation and operation on the user computer system.
9.2.2 Vision Certificate of Validation
A Certificate of Validation is included with every Vision Software Package. This states that Vision is
validated and is signed by an officer of FOSS.