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!