Risk Management · Context Capture

Run Risk Assessment

Declare the risk context, characteristics, and inspection sensitivity. The brief will rank risk by inspection exposure and assess control sufficiency.

Section 1 — Risk Context

Risk Category Select risk category Data Integrity Validation Supplier Process Other

Impact Domain Select impact domain Patient safety Product quality Data reliability Multiple

Regulatory Scope Select regulatory scope FDA EMA Global Other

Section 2 — Risk Characteristics

Likelihood Select likelihood Low Medium High

Detectability Select detectability High Medium Low

Existing Controls Select control strength Strong Moderate Weak

Section 3 — Inspection Sensitivity

Historical Findings Relevance Select relevance Direct Related None

Inspector Focus Area Select inspector focus Yes No

Enforcement Trend Alignment Select enforcement trend Increasing Stable Decreasing

Generate Risk Assessment Brief. The brief will rank risk by inspection exposure and assess mitigation sufficiency.

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