Fusion QbD Analytical Method Validation Software – Overview
The ICH guideline, Validation of Analytical Procedures: Text and methodology Q2(R1) sets out the characteristics of an analytical method that should be considered to ensure a procedure is fit for its intended purpose. Fusion QbD provides a platform to do this efficiently while ensuring data quality and compliance.
The method validation software provides Early Phase characterization routines for internal consumption and help guide the method development process, while Final Phase validation routines produce submittal-quality reports, complying with all FDA/ICH guidelines.
Integration with your chromatography data system (CDS) allows for the validation experiments to be created directly in the CDS as ready to run Sequences. The generated chromatogram results are then pulled back into Fusion QbD via the same compliant, file-less data exchange interface. This CDS interface irradiates the need for manual creation of methods (Robustness) and sequences in the CDS and data transcription out of the CDS. This in turn removes the need for transcription checking. The result is a large time saving of up to 85% whilst guaranteeing data quality.
The Quality by Design approach taken for Robustness ensures a statistically valid Design Space is constructed to properly demonstrate Robustness.
The 21 CFR Part 11 compliance toolset delivers user access control, full audit trail, and electronic signature functionality. Together these ensure Fusion QbD Analytical Method Validation Software is the perfect solution for regulated environments. Finally Fusion QbD is available as a single workstation or a network deployment and is certified to run in a Citrix environment.
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