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Fusion QbD – Software for Analytical Method Development, Validation, and Transfer
Fully automates method development experiments on multiple CDS systems!
Full Part 11 Compliance support with bi-directional auditing assures Data Integrity!
Characterizes robustness across entire study region to establish true Method Operable Design Region!
Chromatography-centric QbD Software for Analytical Procedure Lifecycle Management
S-Matrix’s Fusion QbD Software Platform for Analytical QbD is a comprehensive integration of chromatography-centric and advanced statistical tools in an automated platform 100% aligned with Quality by Design (QbD) regulatory guidances.
Fusion QbD was built for working analytical scientists during years of collaboration with pharma company customers and instrument manufacturer partners. Fusion QbD has one-click Design of Experiments (DOE), one-click hyper-precise chromatography centric modeling, powerful automated UV and MS spectra based peak tracking, and comprehensive robustness simulation using industry accepted metrics aligned with modern regulatory guidances.
The Fusion QbD platform also contains a complete Method Validation experiment suite, including Replication Strategy and Method Transfer support – complete with USP <1210> calculations and reporting. In addition, Fusion QbD contains full CDS automation with ChemStation, Chromeleon, and Empower, including bi-directional audit trail and full Part 11 compliance support to assure cross-platform data integrity!
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