Resources

    Free Compliance Resources

    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.

    checklist

    EU AI Act Readiness Checklist for Life Sciences

    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.

    18-point compliance checklist across 5 categories
    Risk classification decision tree for life sciences AI
    Documentation gap analysis template
    Timeline with quarterly milestones to August 2026
    Evidence requirements mapped to BioCompute Evidence Books

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    whitepaper

    FDA 21 CFR Part 11 Compliance Brief for AI Systems

    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.

    Part 11 requirements mapped to AI system components
    Audit trail architecture diagram for AI pipelines
    IQ/OQ/PQ validation checklist for AI platforms
    Open vs. closed system comparison for cloud AI
    Evidence Engine integration overview

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    guide

    Why Sovereign AI Matters for Regulated Industries

    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.

    Sovereign AI vs. cloud AI comparison
    Data residency requirements by regulation
    Security architecture for HIPAA-eligible AI
    Cost implications of sovereign vs. shared infrastructure
    Case for private AI cores in drug discovery

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