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AgentQ Sample report
Quality Maturity & AI Readiness Report
Example MedTech, Inc. · Medical Devices
3.4/5
Stage 3 · Enlightened
Ahead of ~62% of peers
Dimension scores
Quality Maturity3.6 · Wisdom
Digital QMS3.2 · Enlightened
Regulatory Maturity3.4 · Enlightened
AI Readiness2.4 · Awakening
Priority gaps
AI Readiness: Governance
No defined checks stand behind an AI-influenced product decision, and no named accountability for AI output.
Digital QMS: Audit trail & data integrity21 CFR Part 11
The audit trail is only partial and e-signatures aren’t enforced consistently across quality modules.
Regulatory: Supply-chain resilience21 CFR 820.50
Supplier requirements are met, but continuity and disruption risk aren’t planned for in advance.
Recommended next steps
- 1Formalize CAPA effectiveness checks with defined acceptance criteria.
- 2Pilot AI triage for incoming complaints, with a human-in-the-loop gate.
- 3Consolidate document control into a single validated system of record.
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This is an example, not a live result. Your own report reflects your answers, your sector, and the FDA record.