CCS offers compliance program support for the planning, analysis, implementation, validation and verification of Quality Risk Management methods according ICH Q9 and Q10.
Based on the PIC/S Aide-Memoire PI 038-1 and our best practice program approach we are able to serve our customers with a full-service package for QRM implementation.
Risk management methods and tools:
- Basic risk management facilitation methods
- Failure Mode Effects Analysis (FMEA)
- Failure Mode, Effects and Criticality Analysis (FMECA)
- Fault Tree Analysis (FTA)
- Hazard Analysis and Critical Control Points (HACCP)
- Hazard Operability Analysis (HAZOP)
- Preliminary Hazard Analysis (PHA)
- Risk ranking and filtering
- Supporting statistical tools
Read more: EMA QRM ICH Q9