Chromatography-centric QbD-Software for the Development, Validation, and Transfer of Analytical Methods
The Perfect Software Solution for Analytical Procedure Lifecycle Management
Full support of Part 11 compliance / Cross-platform data integrity / Meets all regulatory guidelines and requirements
The Fusion QbD Software Suite consists of four independant modules:
- Fast, Automated Screening of Multiple Column and Mobile Phase Chemistries
- Supports All Separation Modes – e.g. RPC / NPC / SEC / IEX / HILIC / Chiral / SFC
PeakTracker ™ - Automated PDA&MS Spectra Based Peak Tracking
Automates, optimizes and simplifies the use of PDA and MS data in LC and LC/MS method development. Complex challenges PeakTracker can address include:
- Auto-deconvolution of Co-eluted Peaks
- ZTwo or More Peaks with Identical Mass
- Non-ionizing & Non-absorbing Compounds
Optimization with Integrated Robustness
- Fully Characterizes Robustness Throughout Entire Experimental Region
- Establishes Robust Method Operable Design Region (MODR)
- Simultaneously Address All Your Suitability Requirements
- Regulatory Accepted Robustness Metrics – e.g. Cp, Cpk, Cpm, % RSD, …
Forced Degradation Studies
Fusion QbD - FMD Features
- Full Automation Support
- Peak Tracking Across Deg. Samples
- Composite Chromatogram Modeling and Visualization
Full Method Validation Experiment Suite
Fusion QbD - FMV Features
- Calculations and reporting meet all current FDA/ICH/USP validation guidances – including the new USP‹1210›!
- Can be used for LC and Non-LC methods (e.g. GC, CE, Q-NMR)!
- Automates LC method validation experiments on multiple instruments and CDS systems!
- Regulatory accepted validation for both Small & Large Molecules!
- Statistically rigorous and defensible robustness testing!
- VHandles multiple compounds – creates complete reports for each!
- Shortens your LC method validation time by as much as 75%!
Quality by Design on a Plate!
If you are wondering where to start when implementing Quality by Design in your organization, Fusion Product Development (FPD) is the answer you've been looking for. With automated experimental design selection, validated data exchange, sophisticated data analysis tools, and comprehensive reporting, FPD is the perfect place to start your QbD journey.
Fusion QbD - FPD Features
The only fully automated off-the-shelf software solution for in vitro inhaler testing!
Fusion QbD - FIT Features
- Can be used for all DUSA and Inhaler Testing work – ACI, MMI, MSLI, FSA, FSI, and NGI®!
- Automates LC work on multiple instruments and CDS systems!
- Part 11 support for regulatory compliance!
- Built-in workflow management system with secure templating!
- Reduces or eliminates labor intensive manual data and report review!
- Reduces analyst time by a minimum of 40%!
If you would like to get to know the product, you are welcome to contact cromingo for a demo appointment. But you are also welcome to contact us for individual questions or a discussion about this product. Extensive information about the product can also be found on the manufacturer's website of S-Matrix Corporation: smatrix.com.