Expert guides, checklists, and briefs to help your life sciences team navigate AI compliance — from FDA 21 CFR Part 11 to the EU AI Act.
A step-by-step checklist to assess your organization's readiness for the August 2, 2026 EU AI Act enforcement deadline. Covers risk classification, documentation requirements, conformity assessment, and evidence generation.
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A concise technical brief covering how AI systems must comply with FDA's electronic records regulation. Includes audit trail architecture, validation frameworks, and electronic signature requirements.
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A guide explaining sovereign AI architecture and why it's becoming essential for life sciences organizations handling sensitive data under HIPAA, GDPR, and GxP regulations.
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