Decision Ownership · Context Capture

Map Decision Ownership

Declare the decision context, ownership structure, and governance controls. The brief will classify authority, identify ambiguity, and surface inspection risk.

Section 1 — Decision Context

Decision Type Select decision type Validation Change Control Data Integrity Supplier Qualification Risk Acceptance CAPA Closure Other

Regulated Area (GxP Domain) Select regulated area GMP GCP GLP GDP CSV / Computer Systems Multi-domain Other

Lifecycle Stage Select lifecycle stage Draft Approved Implemented Retired

Section 2 — Ownership Structure

Decision Owner Role Select owner role QA IT Engineering Operations Regulatory Affairs Management / Executive Not defined

Approval Model Select approval model Single owner Joint approval Committee Not defined

Delegation Status Select delegation status Direct Delegated Inherited Not defined

Section 3 — Governance Controls

SOP Coverage Select SOP coverage Explicit Partial None

RACI Alignment Select RACI alignment Defined Ambiguous Missing

Escalation Path Defined Select escalation status Yes No

Generate Decision Ownership Brief. The brief will assign accountability, classify ambiguity, and surface inspection risk.

Map Decision Ownership →