Metrohm NIRS XDS SmartProbe Analyzer - Manual (Page 87)

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• 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.
9.1.4 Metrohm Master Instrument Program
In support of our worldwide base of instruments, Metrohm maintains a Near-Infrared Master
Reflectance 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, Metrohm 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.
9.2.3 Vision Validation Document Package
This Compact Disc (CD) contains full
documentation of the Vision Spectral Analysis
Software design process. This CD is available for
purchase through your Metrohm Distributor.
Documentation begins with the original Functional
Requirement Specification, Software Requirement
Specification, Architecture Documents, Code
Reviews, Test Results, Acceptance Tests, and other
important information.
Running to several thousand pages, this CD will satisfy your Internal Audit Staff and external
regulators that Vision Software was designed from the first moment to be a fully code-validated,