S-Matrix Corporation

S-Matrix is a world technology leader in Automated QbD Software to support Analytical Method Development, Validation, and Transfer of chromatography methods. S-Matrix’s Fusion QbD® Software is a comprehensive integration of chromatography modeling and advanced statistical capabilities supporting all stages of Analytical Procedure Lifecycle Management. Flexible DOE technology, automated UV and MS spectra based peak tracking, and hyper-precise modeling of any chromatography results data enable Fusion QbD to support all separation modes and all stages of method development from identifying initial method conditions through chemistry system screening (method scouting) to final robust method optimization, 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 optimization and Replication Strategy optimization 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 USP <1220>, ICH Q14, and ICH Q2(R2). Fusion QbD’s strategic regulatory compliance and data integrity supporting 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.