Learning statistical experimental design and data modelling theories normally requires a lot of time and effort from the layman. However, without profound knowledge about this, conventional statistical software cannot be used correctly and effectively and errors are inevitable. In everyday business life, however, it is usually not possible to acquire the required depth and expertise on one's own and a statistician must be consulted for such tasks.
With the technology of S-Matrix, software solutions are offered by which even the statistical layman can create and evaluate DoE experiments by the click of a button.
Fusion QbD is a modular software platform providing bidirectional data exchange to various chromtography systems and complete CFR21 Part11 support.
The application of QbD principles is common in product development. Unique feature of the Fusion software is the configured application of these principles to the development of chromatographic methods. Traditionally, LC methods are mostly developed according to the OFAT (One Factor At a Time) principle. This approach is not only time consuming, but also suppresses the effect of interactions between the considered qualitative and quantitative effects. Only by examining all levels for all factors under consideration, one can gain a clear understanding of the contexts.
However, this approach would lead to immeasurably long series of experiments and is therefore hardly practicable. By applying Design of Experiments (DoE), these experiments can be reduced by a factor of 5 and still obtain a complete picture of all the effects of the considered chromatographic factors for the entire experimental region and get a quantitative statement for them.
Fusion QbD® is the only software for method development that uses the real and complete QbD package in line with ICH Q8(R2 ). All predictions are based on empirical models generated from experimental raw data, not theoretic "first principle" functions or in-house algorithms. This allows Fusion QbD to be applied to all separation methods: Chiral, HILIC, Ion Exchange, Size Exclusion, Normal Phase and, of course, Reverse Phase. Fusion QbD is also great for difficult sample matrix where classic baseline separation is not achieved.
QbD aligned method development and robustness optimization software with built in compliance and automated LC experimentation.
Regulatory compliant validation for small and large molecule API and product. Also used successfully for Non-LC method validation (e.g. CE, GC, Q-NMR).
The perfect QbD-aligned software for formulation and process development as well as for the development of non-LC methods - wizard-driven experimental design, automated analysis and modeling, integrated Monte Carlo robustness simulation, elegant effect visualization graphics and comprehensive reporting. Especially suitable for the development and investigation of sample preparation methods.
Create sampling plans, export and import data from your CDS via validated data exchange, calculate particle size distribution results, and generate reports according to USP 601, Ph.Eur. 2.9.18, and ISO 27427.
Agilent ChemStation/OpenLAB Data Exchange module
Thermo Chromeleon Data Exchange module
Waters Empower Data Exchange module
Fusion Pro is an expert system standalone software which is completely aligned with Quality by Design principles, and designed for working scientists and engineers. The software provides a complete suite of Design of Experiments (DOE) technologies, including advanced data modeling and Monte Carlo simulation modeling capabilities, to support your R&D work within a simple workflow based work environment. Fusion Pro is the perfect Design of Experiments (DOE) software for formulation studies, Process Optimization, and Product Development, from initial screening through final optimization.
If you only need a DoE software without interface to a chromatography software and without regulatory framework, then Fusion Pro is the product of your choice. Fusion Pro is available as stand-alone software but also as a network solution.
We would be pleased to make you an individual offer. The following information is required for this:
You can also use the request form: Quotation Request Form Fusion