ValPro™ System Qualification Software for NIR Analyzers

Achieve cGMP and FDA regulatory compliance with the Thermo Scientific™ ValPro™ System Qualification Software for NIR Analyzers. Providing a full set of tools for DQ, IQ, OQ and PQ testing of the Thermo Scientific™ Antaris™ FT-NIR Analyzers, this package includes software, extensive documentation and a validation wheel with NIST™ traceable and USP-recommended standards.

The ValPro System Qualification Software for NIR Analyzers Features:

• Instrument and software DQ documentation
• Installation procedures, testing routines and documentation for IQ
• 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
• Troubleshooting tree to resolve instrument problems
• Serialized, traceable NIST standards
• 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
• Detailed installation documentation
• Installation and instrument certification
• Example OQ and PQ procedures