S-Matrix’s Fusion QbD® Software Platform provides advanced tools and automation to support Analytical Methods Development, Validation, and Transfer; Formulation and Process Development; and Respiratory Drug Product Development and Quality Control. Strategic capabilities within Fusion QbD include full automation for statistical Design of Experiments (DOE, DoE), integrated data management and complex data treatment automation, advanced data modeling, fully integrated Monte Carlo robustness simulation, numerical and graphical optimization, and complete reporting with multi-format output options. For Analytical QbD, Fusion QbD supports all stages of Analytical Procedure Lifecycle Management with automated UV and MS spectra based peak tracking and hyper-precise modeling of any chromatographic results which enable Fusion QbD to support all chromatographic separation modes and all stages of method development from identifying initial method conditions through establishing the robust (MODR). Fusion QbD also supports Sample Preparation method optimization and full automated experimentation support for method validation and transfer, including Replication Strategy optimization and integration of USP Interval metrics. Fusion QbD is 100% aligned with all current regulatory guidances, along with all methodologies and approaches in the new guidances. Fusion QbD’s strategic regulatory compliance and data integrity support features include full CDS automation with complete bi-directional audit trail for ChemStation, Chromeleon, and Empower, full Part 11 compliance support, and a built-in Project Management System.