Checklist
GxP AI Readiness Checklist
A practical assessment for AI use in regulated Pharma & MedTech environments
AI is entering more and more processes across Pharma and MedTech. Yet in GxP environments, every innovation must be backed by evidence of control, validation, and compliance. This practical readiness checklist helps you evaluate whether your AI solution or agent has the required oversight, documentation, and safeguards to operate safely in regulated workflows.
Use this checklist to:
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Review your current controls across regulatory compliance, validation, data integrity, auditability, security, and governance
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Identify gaps that may introduce compliance risk before auditors discover them
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Understand which controls require additional justification, documentation, or risk mitigation
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Determine a high‑level readiness score (0–100) across 50 key criteria
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Support a risk‑based approach aligned with ICH Q9 and EU GMP expectations
Get started now and discover your AI solution’s GxP readiness.
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