Audit Readiness · Context Capture

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Declare the regulatory scope, evidence state, and inspection exposure. The brief will classify readiness signals and surface likely inspection failure domains.

Section 1 — Regulatory Scope

Primary Regulator Select primary regulator FDA EMA MHRA Multiple Other

GxP Domain Select GxP domain GMP GCP GLP CSV / Computer Systems Multi-domain Other

Inspection Type Select inspection type Routine For-cause Pre-approval Mock / Internal

Section 2 — Evidence State

Audit Trails Available Select availability Yes — complete Partial No

Data Integrity Controls (ALCOA+) Select control strength Strong Moderate Weak

System Validation State Select validation state Validated Partially validated Not validated Unknown

Section 3 — Inspection Exposure

Inspected in Last 24 Months Select prior inspection status Yes — clean Yes — observations Yes — findings No

Change Control Maturity Select change control maturity Controlled Inconsistent Ad hoc

CAPA Backlog Status Select CAPA status Current Lagging Unknown

Generate Audit Readiness Brief. The brief will classify readiness signals and surface likely inspection failure domains.

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