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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  • Implements a structured approach and consistent reporting of your validation process
  • Eliminates transcription and transcription errors
  • Significantly reduces analyst error
  • Achieves significant time savings of up to 85%
  • All within a 21 CFR p11 compliant platform suited to a GMP environment
  • Analytical Capability and System Suitability
  • Specificity
  • Filter Validation
  • Accuracy
  • Linearity and Range
  • Limit of Detection (LOD) and Limit of Quantitation (LOQ)
  • Repeatability
  • Sample Solution Stability
  • Analytical Capability and System Suitability
  • Specificity
  • Accuracy/Linearity and Range/Repeatability (ICH-Q2A combined experiment)
  • Limit of Detection (LOD) and Limit of Quantitation (LOQ)
  • Intermediate Precision and Reproducibility (USP Ruggedness)
  • Robustness

The evaluation of Robustness has undergone a radical change in recent years as the quality by design approach has become favoured by regulators. The small incremental changes performed historically were error prone and performed in a “vacuum” of knowledge. The QbD approach provides far greater knowledge with wider ranges studied to reduce overall error and give visibility of the methods edges of failure. Fusion QbD Method Validation software utilises the tools developed for method development and employs them here to ensure the generation of a statistically valid Design Space within which Robustness can be properly demonstrated.

  • Waters® Empower™ (II & III)
  • Agilent® Chemstation™
  • Agilent® OpenLab (Chemstation Edition)™
  • Thermo® Chromeleon™
All these tools exist in a fully audited, user access controlled, 21CFRp11 compliant networked platform. This makes Fusion QbD the perfect analytical method validation software, fit for purpose in today’s method validation laboratory.

You may also be interested in Fusion QbD for HPLC Method Development

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