QRM Projects
We can assist you to migrate your historical dataQRM Projects
iRISKTM 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