Advanced Chromatography Software for LC Method Development, Validation, and Transfer

S-Matrix is a world technology leader in Automated Quality-by-Design (QbD) Software to support Chromatographic Analytical Method Development, Validation, and Transfer. S-Matrix’s Fusion QbD® Software is a comprehensive integration of chromatography modelling and advanced statistical tools supporting all stages of Analytical Procedure Lifecycle Management (APLM). Flexible Design of Experiments (DoE) technology, automated UV and MS spectra based peak tracking, and hyper-precise chromatographic modelling of any integrated peak results enable Fusion QbD to support all chromatographic separation modes and all stages of method development from identifying initial method conditions through chemistry system screening (method scouting) to final robust method optimisation, including full forced degradation study automation and integrated robustness simulation for all included critical System Suitability performance characteristics throughout the entire experimental region – the correct basis for accurately establishing the robust Method Operable Design Region (MODR). Fusion QbD also supports Sample Preparation method optimisation and Replication Strategy optimisation with full integration of USP <1210> Interval metrics. Additionally, Fusion QbD contains a full automated experimentation suite for method validation and transfer. Fusion QbD is 100% aligned with all current regulatory guidances and contains the core QbD methodologies and tools presented in ICH Q2(R2), ICH Q14, and USP <1220>. Fusion QbD’s strategic regulatory compliance and data integrity support features include full CDS automation with ChemStation, Chromeleon, and Empower with complete bi-directional audit trail, full Part 11 compliance support, and a built-in Project Management System.

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