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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.
| 使用対象 (装置) | RESULT and Antaris NIR spectrometers |
| タイプ | ValPro System Qualification for NIR Analyzers |
| 認証／コンプライアンス | FDA, USP, EP, 21 CFR Part11 |
| 概要 | Developed specifically to help with cGMP and FDA regulatory compliance, ValPro™ System Qualification Software for NIR Analyzers provides a full set of tools for DQ, IQ, OQ and PQ testing of the Thermo Scientific™ Antaris™ FT-NIR Analyzer. |
| 使用対象（アプリケーション） | Tools for DQ, IQ, OQ and PQ testing |
| Unit Size | Each |
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| VALPRONIR | Each | RESULT and Antaris NIR spectrometers | 見積もりを依頼する | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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
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