DOE-based software with a complete library of design types

Fusion LC Method Development

Automated Quality by Design based LC method development software with rapid multi-column and multi-solvent screening and novel data treatments to minimize manual chromatogram processing. Method optimization includes built-in robustness metrics. Graphical visualization and reporting of multi-dimensional robust Design Space (Method Operable Design Region — MODR) and Proven Acceptable Ranges (PARs). Works with a wide variety of LC systems, and supports both internal and external column/solvent switching valve control. MORE»

Fusion Analytical Method Validation

Complete Analytical Method Validation software system with Early Phase performance characterization and Final Phase submittal-quality validation options. Full experiment suite and LC automation for Small and Large molecule LC methods. Also used successfully for a wide variety of non-LC methods (e.g. QNMR, CE, GC-MS, LC-MS). Analysis and reporting complies with all FDA/ICH Guidances. MORE»

Fusion Product Development

Designed for working scientists and engineers. Supports QbD experiments for development and optimization of formulations, processes, and Non-LC Analytical Methods. Fusion Product Development combines advanced Data Mining with state-of-the-art Design of Experiments (DOE) capabilities. Some of the strategic DOE technologies unique to Fusion Product Development include (1) Global Preferences Settings — Automated mode (novice users) and a User-interactive mode (advanced users) for experiment design and data analysis, (2) integrated Monte Carlo robustness simulation, and (3) Data Mining — examines existing data sets for required cause-and-effect information. If key information is missing, Fusion Product Development can generate extremely efficient "Repair" experiments that provide the required information with minimal additional lab work. MORE»

Fusion Inhaler Testing

Fusion Inhaler Testing (FIT) software module includes all of the analytical results and graphs typically required for Inhalation scientists. FIT automatically generates complete experiment plans for USP Apparatus 1–6 (EP Apparatus A, C, D, and E), and Dose Unit Sampling Apparatuses (DUSAs). FIT builds coordinated LC testing protocols in chromatography data systems (CDS) as ready to run sequences, imports all chromatographic results, automatically computes all results and graphs, and generates a full suite of regulatory aligned reports which meet USP and EP requirements. MORE»