QRM Projects

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QRM Projects

iRISK is a consequence of our decade-long experience delivering Quality Risk Management projects to the industry worldwide. Our QRM Team has a vast knowledge on how QRM must be applied in the demanding context of the pharmaceutical industry.
  • Criticality Assessments
  • End-to-end process Risk Assessments
  • QRM application for the 3 Stages of Product & Process Development
    • Stage 1 – Design and Development
    • Stage 2 – Equipment & Process Performance Qualification
    • Stage 3 – Continued Process Verification
  • Seamless transfers between Lifecycle Stages
  • Retrospective QbD for legacy products
  • Risk-based Supplier Sourcing & Qualifications
  • GAP Analysis

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