Compliant with PAT, QbD and 21CFR

  • Experiment design wizard
  • Powerful data import
  • Modeled on-line Monitoring

PAT has put emphasis on process and formulation understanding. MVA & DoE is advocated by recent regulatory guidances, particularly ICH Q8 and the US FDA's QbD initiative. The Unscrambler® X provides important tools for process understanding, optimization and calibration of models.