Metrohm NIRS XDS RapidLiquid Analyzer - Manual (Page 75)

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customer testing. Included with your instrument are results from Instrument Noise, Bandwidth,
Wavelength Accuracy, Photometric Certification, and Wavelength Certification. These factory tests
are performed under controlled, ideal conditions, and serve as an important baseline for all
subsequent testing.
Test results are included for each module or configuration ordered. These test results are included in
an informative brochure that explains the tests, what they measure, and how they relate to
instrument performance. The Instrument Test Guide and the user instrument test results form the first
part of the instrument log recommended by regulatory bodies.
9.1.2 Installation and Operating Qualification Documents
Laboratory-based Industrial instruments come with Installation Qualification (IQ) and Operating
Qualification (OQ) Documents included as part of the Vision® Spectral Analysis Software package.
These documents are presented in checklist fashion, to guide the user through each step of
instrument set-up and qualification.
9.1.3 NIRStandards® for Instrument Performance Verification
Various regulatory bodies suggest (or require)
regular testing of NIR instrumentation to
verify continuing stability of photometric and
wavelength response. These transmission
standards operate with Vision Software.
Vision records "first use" instrument response,
and permits regular verification of subsequent
response to the original measurements.
NIRStandards are designed for easy use with
all Metrohm XDS Rapid Liquid Analyzers in the
pharmaceutical industry.
The standards are calibrated on our Master Instrument for use with in Instrument Performance
Verification.
9.1.4 Instrument Performance Certification
The United Code of Federal Regulations, Title 21, requires user testing, as well as periodic testing of a
deeper nature to assure instrument response and reliability. Instrument Performance Certification
(IPC) is offered to meet these requirements. It is performed every six (6) months, on site, by a certified
technician. Some key program features:
• Measures instrument response using standards calibrated to Metrohm Master Instrument
Assures consistent response between instruments of identical design.
• Performed by factory-trained service personnel
Periodic maintenance is performed on-site to assure consistent ongoing performance.
• Serves as Installation Qualification and Operating Qualification for new instrument
installations
Meets CFR 21 requirements for instrument qualification.