We aim to reduce Research & Developement Time & Costs

QbD-Xpert©

The software to support your entire QbD steps during R&D stage considering Focus Areas, Risk Matrix, Scoring and predetermined in vitro or in vivo endpoints based on clinical considerations for design space.

Salient Features:

  • Process Block Diagram & Input/Output Diagrams
  • Material Attribute and Process Parameter Brainstorming with output stored as Ishikawa(Fishbone) Diagrams
  • Quality Target Product Profile (QTPP) creation templates
  • Critical Quality attributes for individual or groups of process steps with severity scoring
  • Formulation and Initial Process Risk Assessment Tool (Preliminary Hazard Analysis)
  • Process Risk Assessment tools (Cause & Effect matrix and FMEA) with Justifications
  • Optional Decision Confidence Scoring for Risk Assessments
  • Ability to link every decision taken in a risk assessment to the output
  • Multiple outputs from Risk Assessments including Pareto plots and Heat-map charts
  • Multiple Risk Assessments per step with automatic "What's changed" view
  • Design of Experiments (DOE) - two level factorial screening and response surface designs using Plackett-Burman & Central

Composite Design & D-optimal Models:

  • DOE output options include half normal plots, 2D contour and 3D surface plots
  • Prediction of plasma concentration time profile from in vitro dissolution to define the design space