Fusion QbD® from S-Matrix® Corporation

As a service and distribution partner of S-Matrix® Corporation, cromingo® offers acquisition, support, training and qualification for the Fusion QbD® software in the DACH region. cromingo® is your official point of contact for all aspects of connecting Fusion Software to Waters™ Empower™ in Germany, Austria, Switzerland and neighbored countries.

What the Fusion Software can do can not be put into a few words. A glance at the word cloud should provide an overview in a nutshell:

Fusion QbD

high-quality chromatography using qbd

The application of QbD principles is common in product development. Unique feature of Fusion Software is that these principles are fully applied 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 drivers. Only by examining all levels for all the 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.

new features

Fusion QbD® is constantly being developed and improved to be able to offer a needs-based and high-quality product.

Get to know the latest features: Simulated Chromatograms for the entire Design Space (Prediction Chromatograms), Predicting Your Quality Attributes (Predicted Response Data) and Buffer Selection for Automatic pH Adjustment: Fusion QbD News

You want to know more about it? Then make a demo appointment today:

Schedule an appointment

statistics for non-statisticians

The application of statistical models and evaluations automatically takes place in the background and the analyst can concentrate solely on his analytical questions. Profound statistical skills are not required for using Fusion software. It is sufficient if you can correctly interpret the calculated statistics. We look forward to assisting you in this.

Automatic data exchange with your cds

The integration of the software into a CDS via a validated interface is certainly interesting. In no time at all, this allows you to create series of measurements in the CDS for many devices without further intervention. After completion of the measurement and evaluation by the CDS, selected Peak Responses are returned to the Fusion Software for further data modeling.

This is how Fusion QbD® turns your HPLC into a veritable method development machine. The software supports rapid column and eluent switching along with dynamic preparation of aqueous solutions (e.g., for buffer or pH screening).

An innovative processing of the data via patented Trend Responses™ overcomes the difficulties encountered with traditional peak tracking. The interface connection to the CDS not only makes data exchange faster, but also prevents transmission errors.

integrated qbd toolss

In addition to statistical design, Fusion uses software tools to calculate and evaluate the robustness of your method (Monte Carlo simulation, statistical indices for the robustness of the process). With Fusion Software, you not only save time in method development, but also gain a clear understanding of your method and the certainty of having developed a high-quality method that not only best matches your defined target profile based on an immense amount of data, but by defining a design space and applying process capability indices, it will work reliably over the entire period of the method lifecycle.

21 cfr part 11 readiness

The software offers extensive user management via groups and configurable user roles, a complete audit trail, the ability to define workflows and request electronic signatures. The exchange with the CDS is fully audited in both directions and on both sides.

your benefit at a glance

  • generation of robust and acceptable methods
  • apply Quality by Design to your LC method development process
  • you save time
  • maximizing system utilization
  • elimination of transmission errors
  • reduction of the risk of error in the validation or transfer of your LC method
  • 21 CFR part 11 compliant
Fusion Method Development: Fundamentals

qbd plattform

The entire software platform consists of four equivalent modules. In addition to Fusion Method Development, the modules Method Validation, Product Development and Inhaler Testing are also offered. You decide which modules you need:

In addition to integration with Waters™ Empower™, the platform also supports Thermo Chromeleon and Agilent OpenLab (ChemStation).

For classic use in product development, we also offer a version without the regulatory overhead and without the possibility to connect to a CDS:

more information

If you would like to get to know the product, you can contact cromingo® for a demo appointment. But you can also get in touch with cromingo® for any questions or conversation about this product. Extensive information on the product can also be found on the manufacturer side of S-Matrix Corporation: