Fusion QbD®

Quality by Design Software Platform

APLM Stages

Analytical QbD

Chromatography-centric QbD Software for the Development, Validation, and Transfer of Analytical Methods

  • LC, LC-MS, SFC
  • Sample Preparation
  • GC, CE, Dissolution, and More...

Follow the Analytical Procedure Lifecycle
Management Workflow with Fusion QbD!

Rapid Chemistry System Screening

Rapid Chemistry System Screening

A rigorous quantitative approach to stationary and mobile phase chemistry selection (method scouting)

Patented Trend Responses automatically extract critical information on shape and selectivity from each experiment chromatogram without the need for peak tracking at the screening stage

Quickly identify critical method parameters and
select study ranges for follow on optimization experiments

Robust Method Optimization (LC, LC-MS, SFC, …)

Robust Method Optimization

Revolutionary method optimization with:

  • Flexible DOE Experimental Design
  • Automated UV & MS Based Peak Tracking
  • Retention-based Resolution Modeling
  • Monte-Carlo Robustness Simulation
  • Forced Degradation Study Automation
  • Non-LC Method Development (GC, CE, Disso., …)

Establish the Method Operable Design Region (MODR)
for all Critical Analytical Method Attributes

Sample Preparation Method Optimization

Sample Preparation

Rapid Screening to identify all Critical Method Parameters

Full CDS automation for LC testing

Robust Optimization with Monte-Carlo Robustness Simulation

Establish the Method Operable Design Region (MODR)
for all Critical Sample Preparation Method Attributes

Interval Test

Replication Strategy Optimization

The number of individual measurements described in the analytical procedure which contribute to the calculation of the reportable result.

  • Characterize the Total Analytical Error (TAE)
  • Quantify the Percent Contribution of Sample Preparation and Sample Injection to the TAE
  • Combine Accuracy (Bias) and Precision using
    USP <1210> Interval Metrics

Identify the Optimum Replication Strategy for
All Critical Analytical Method Performance Requirements

Analytical Method Validation

  • Analytical Capability
  • Specificity
  • Filter Validation
  • Sample Solution Stability
  • Accuracy / Linearity / Repeatability
  • LOQ, LOD
  • Robustness
  • Intermediate Precision
    & Reproducibility

Comprehensive Method Validation Experiment Suite Meets all FDA, ICH, and USP requirements and guidances, including ICH Q2, USP <1210>, USP <1220>

  • Small Molecule – traditional pharmaceutical substances and products
  • Large Molecule – the only complete and automated method validation software for biopharmaceutical products (e.g., MAbs)
  • Non-LC Methods – also used for a wide variety of analytical methods (e.g., CE, GC, QNMR, …)

Full CDS Automation / Full Regulatory Compliance / Maximum Efficiency

Analytical Method Transfer

Analytical Method Transfer

Method Transfer Studies Across Multiple Labs / Sites with Full CDS Automation

Stage 3 – Ongoing Method Performance Verification

Interval Test

Monitoring the analytical procedure during routine use. Confirming that the performance continues to meet ATP criteria

Knowledge Gained from APLM Stages 1 and 2 Feeds Directly into APLM Stage 3

APLM Stages 1 and 2

Fusion Method Validation

Chromatography-centric QbD Software for Analytical Method Validation and Transfer

S-Matrix – Software Solution Partner of:

Meets all FDA, ICH, and USP requirements and guidances, including ICH Q2(R1) and new USP <1210>.

Comprehensive Method Validation Experiment Suite
  • Analytical Capability*
  • Specificity
  • Filter Validation
  • Sample Solution Stability
  • Accuracy*
  • Linearity and Range
  • Repeatability*
  • Accuracy/Linearity/Repeatability*
    • [ICH-Q2(R1) – can be done as a single combined experiment]
  • LOQ, LOD
  • Intermediate Precision & Reproducibility (USP Ruggedness)
  • Robustness – done the right way!

*Method Transfer Studies — Support Includes USP ⟨1210⟩ Tolerance &
Prediction Intervals

Key Benefits
  1. Full Automation – Phased Method Validation
    • Early Phase – performance characterization supports development
    • Final Phase – Aligned with FDA and ICH guidances
  2. 21 CFR 11 compliance support toolset
    • Including E-records and E-signatures, full audit logging
    • Workflow management system with E-review and E-approve loops
  3. Easy setup of experiments
    • Create standardized workflow templates
    • Facilitate rigorous practice and defensibility
  4. Simple documentation review and reporting
    • Easy to defend and communicate
    • Reports meet all FDA and ICH guidelines
Links to More Information about Fusion LC Method Validation!

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