Metrohm NIRS XDS SmartProbe Analyzer - Manual (Page 86)

84 ▪▪▪▪▪▪▪
customer testing. Included with your instrument are results from Performance Test, Photometric Test,
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.
9.1.1 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.
9.1.2 NIRStandards® for Instrument Performance Verification
Various regulatory bodies recommend regular testing
of NIR reflectance instrumentation to verify
continuing stability of photometric and wavelength
response. These reflectance standards include
Metrohm IPV® Software. It 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 reflectance instruments used in the
pharmaceutical industry, and most Metrohm
instruments used in other industries. They are
calibrated on our Master Instrument for use with the
Instrument Performance Certification Program.
9.1.3 Instrument Performance Certification
The United States Code of Federal Regulations, Title 21, recommends regular instrument 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.