ValPro™ system qualification for NIR Analyzers provides a full set of tools for DQ, IQ, OQ, and PQ testing of the Antaris™ FT-NIR analyzer.
• Complete instrument & software DQ documentation
• Automated operation of all instrument tests
• Complete instrument tests for system stability and performance
Product Detail
Today, your company must comply with extensive industry and government regulations. Our ValPro™ system qualification package was developed specifically to help with regulatory compliance. This package includes software, extensive documentation, and a validation wheel with NIST traceable and USP-recommended standards. Together with our system qualification services, this package offers all the tools necessary to certify system performance. ValPro is a complete system validation package developed to allow for compliance with cGMP and FDA regulatory requirements. It contains all of the necessary components to comply with testing of:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ); When used in conjunction with RESULT software, ValPro provides complete spectrometer performance qualification.
ValPro system qualification package also offers:
Complete instrument & software DQ documentation
Complete installation procedures, testing routines and documentation for IQ
Complete instrument tests for system stability and performance
Pharmacopeial-recommended instrument tests for wavelength accuracy, spectrophotometric noise and photometric linearity
Automated operation of all instrument tests
A complete troubleshooting tree to resolve instrument problems
Serialized, traceable NIST standards
The ability to independently validate the instrument, sampling techniques and methods
Templates and test limits for other NIST, NPL or user-defined Product testing standards
Templates for recommended qualification standard operating procedures (SOPs)
Historical, tamper proof validation reports with audit trails
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