Measure quality risk and tie it to decisions and records
Collect risk assessments in structured FMEA records and feed RPN scores into validation scope, change classification and CAPA priority.
ICH Q9(R1) risk management
ICH Q9(R1)EU GMP Annex 15GAMP 5 (2nd ed.)
Quality Risk Management
Axon · RISK
Illustrative interface rendering. Real screens and recordings live on the module pages.
Quality Risk Management
Who it is for: Quality risk managers, process engineers, validation teams
FMEA and RPN scoring
Calculates RPN from severity, occurrence and detectability and shows risk level with colors.
CPP and CQA traceability
Links critical process parameters and critical quality attributes to risks.
Risk-based decision input
Risk level is used as a reference for validation scope, change class and CAPA priority decisions.
Signed review
Risk assessments are approved with e-signature and audit trail; versions can be compared.