USA13: How a Top Pharma Firm Traded Regulatory Checklists for Enterprise Architecture Governance

Overview:

In pharma, a persistent pattern is using regulatory SOPs as a proxy for EA governance.

Trials, quality events, and submissions followed procedure — yet no enterprise model connected R&D, manufacturing, serialization, and pharmacovigilance.

P1–P6 Insight Preview:  SOPs stabilized local processes (P2) and components (P4), but lacked enterprise governance (P1) and system behavior traceability (P3).

Implementation tickets (P5) multiplied; business + tech ops (P6) struggled to reconcile deviations across functions.

Role Disconnects:

1. CEO: “We’re inspection-ready” — but cross-domain change remains ad hoc.
   

2. CIO: “Quality events flow through systems” — with duplicated rules everywhere.
   

3. Sales Head: “Launch windows are met” — supply/label changes break post-launch.
   

4. Chief EA: “We govern documents, not design” — the enterprise logic is unowned.

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