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Molecul ar Spectroscopy

Produ c t Spe ci f i cat i ons


Thermo Scientific
ValPro System Qualification for
FT-IR and Raman Spectrometers
Comprehensive spectrometer validation tools

Thermo Scientific ValPro System


Qualification for FT-IR and Raman
spectrometers is the most complete
and cost effective method of
addressing all of your regulatory
compliance needs.

ValPro™ System Qualification for Thermo Complete System Qualification


Scientific FT-IR, FT-Raman and dispersive ValPro qualification tools cover the entire
Raman spectrometers provides the most system by including standards and
complete set of system qualification tools procedures for Thermo Scientific FT-IR and
in the industry. Designed to meet Code Raman spectrometers, as well as sampling
of Federal Regulations (CFR), systems accessories such as ATR and diffuse
qualified with ValPro can stand up to the reflectance. ValPro significantly reduces the
most stringent governmental or industrial time and financial investment required for
regulatory reviews. Thermo Scientific system qualification by providing:
common system qualification methodology
makes ValPro the fastest and most cost • Traceable reference standards designed
specifically for each system and accessory
effective means of achieving complete
system compliance. • Comprehensive procedures documenting
installation and operation in your laboratory
ValPro gives you the ability to: • Methods that comply with European and
Japanese Pharmacopoeias or ASTM practices
✓ Qualify the spectrometer
• E xpert qualification services delivered by
✓ Qualify the sampling module certified personnel
✓ Qualify the analysis software These features make qualification simple
Its integrated approach allows you to get and ensure proper installation of the system,
your system into commission quickly. giving you complete confidence in the results.
Installation Qualification Design Qualification Operational Qualification
Detailed installation procedures, reports and The ValPro system qualification package Following successful completion of IQ,
certification documents are part of every includes extensive documentation explaining ValPro’s Operational Qualification (OQ)
ValPro system qualification package. This our product life cycle management to provides assurance that:
ensures that your spectrometer system address Design Qualification (DQ). DQ • The system is operating correctly
installation complies with Installation documentation details our processes for:
• The software is operating correctly
Qualification (IQ) specifications. These • Qualifying suppliers • System operators are properly trained
procedures verify and document that the
• Documenting projects
equipment is: OQ procedures may include the following
• Testing and releasing products
•D  elivered as ordered and specified in the DQ tests† to assess instrument performance:
• Archiving test results
• Defect- and damage-free • Supporting products • Noise
• Properly installed in an appropriate • Wavelength accuracy
environment Additionally, the package provides specific • Spectral resolution
hardware and software information to
IQ procedures also verify proper installation • Precision
help you determine if the products are
of the software. • Linearity
fit-for-purpose.
You can choose to implement these As with IQ procedures, you can have OQ
The documentation provides detailed software
procedures using your own personnel, or completed by your own personnel or by
DQ information. This information explains
have the procedures completed by trained trained and certified support personnel as
how the supplied software products comply
and certified support personnel as part of part of our Installation Certification service
with ISO 9001 protocols and Code of Federal
our Installation Certification service which which links system performance back to the
Regulations for configurable off-the-shelf
establishes traceability back to the factory. original factory data.
software. Procedures are documented for:
• Software coding
† Consult your Thermo Scientific representative
• Code archiving and off-site storage to discuss the qualification needs for your
• Algorithm documentation instrument configuration.
and verification
• Software revision control
and issue tracking
• Software documentation

Nicolet iS50 FT-IR


spectrometer with iS50
Raman module and
built-in iS50 ATR
Performance Qualification ValPro Qualification Software
The ValPro system qualification package The ValPro Qualification software can run
provides guidelines for performance a variety of tests that support your specific
qualification, ensuring that your system is instrument configuration†. This software
working properly for its intended use. ValPro allows you to run the same tests used for
qualification tools, used in conjunction OQ at any time as part of your ongoing
with our consulting services, provide the system performance verification SOP. It can
flexibility needed to accommodate any also execute custom tests implemented to
qualification requirement. This approach address PQ for your system.
allows independent qualification of the
The software:
spectrometer, sampling technique, or
analytical methods. It allows incorporation of • Provides selection of a variety of
any user-defined or industry-recommended performance verification tests.
qualification standards or methods into • Automatically archives spectral data and
result history
the package. ValPro qualification report
• Generates a qualification report that can
Traceable Reference Materials be printed and signed
The ValPro system qualification package • When combined with our 21 CFR Part 11
tools, provides additional security by
provides complete traceability for the
controlling access and using digital
reference materials used to run performance signatures plus detailed audit trails.
verification tests. Whether they are
internationally recognized standards, or
† Consult your Thermo Scientific representative
proprietary materials, these references
to discuss the qualification needs for your
follow our strict traceability process. ValPro instrument configuration.
standards include NIST and NPL traceable
references, as well as proprietary references.

Standard reference materials are provided


in convenient form factors for instrument
sampling configurations. Motorized validation
wheels are available for some system
configurations to allow automated on-demand
or scheduled system testing.

Polystyrene
Reference Cards for
FT-IR Spectrometers

Validation Wheel for


Automated ValPro Testing Thermo Scientific DXR
SmartRaman spectrometer

Raman Polystyrene Reference Accessory

Nicolet iS10 FT-IR


spectrometer with Smart
Diffuse Reflectance accessory
Performance Verification ValPro System Qualification Package Software & System Requirements

Produ c t Spe ci f i cat i ons


Test Methods The ValPro system qualification package • OMNIC 7.2 or later version
The ValPro system qualification package provides you with: • Windows® XP Professional or Windows 7
uses performance verification tests Professional
• Complete instrument and software DQ
prescribed by internationally • OMNIC DS & Thermo Scientific Security
• Complete procedures and documentation
recognized bodies. for instrument IQ and OQ Administration (optional for 21 CFR Part 11
• Test methodologies from European and compliance)
These include:
Japanese Pharmacopoeias, as well as
• European pharmacopoeia ASTM standard practices Configurations
• Japanese pharmacopoeia • Instrument tests for wavelength accuracy, Consult your Thermo Scientific representative
• ASTM standard practices spectrophotometer noise, and photometric to discuss the qualification needs for your
linearity for most systems instrument configuration.
ValPro methods and standards are also • Traceable NIST or proprietary standards
compatible with the existing ASTM E 1421
• Optional automated operation of tests
tests used in our Val-Q system qualification
• Complete troubleshooting and diagnostic
package for those customers who have information
standardized on this approach.
• Templates for recommended performance
verification standard operating procedures
Certified Qualification Experts (SOPs)
For complete traceability and simplified • Historical validation reports with audit trails
regulatory compliance, we provide trained
• Example PQ procedures
and certified support personnel to perform
• Fully compatible with our 21 CFR Part 11
all installation and qualification procedures. compliance tools
Annual re-certification ensures that our
qualification experts stay proficient to
provide you with complete and consistent
qualification support. ValPro system
qualification, in conjunction with our
certified support personnel, assures that
your instruments are installed and qualified
properly – eliminating potential regulatory
difficulties. For third party verification and
continuous compliance, we offer biannual
and annual re-qualification services.

www.thermoscientific.com
©2012 Thermo Fisher Scientific Inc. All rights reserved. Windows is a registered trademark of Microsoft Corporation.
ISO is a trademark of the International Standards Organization. All other trademarks are the property of Thermo Fisher Scientific Thermo Electron Scientific
Inc. and its subsidiaries. This information is presented as an example of the capabilities of Thermo Fisher Scientific Inc. products. Instruments LLC, Madison, WI USA
It is not intended to encourage use of these products in any manners that might infringe the intellectual property rights of others. is ISO Certified.
Specifications, terms and pricing are subject to change. Not all products are available in all countries. Please consult your local
sales representative for details.

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