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What Are Evidence Books?
Evidence Books are per-project, per-regulation compliance packages that contain all the documentation, audit trails, and evidence artifacts required for a specific regulatory framework. They map every AI interaction, validation record, and approval workflow to frameworks like FDA 21 CFR Part 11, EU AI Act, GxP/GMP, HIPAA, ISO 42001, or NIST AI RMF.
Instead of manually assembling compliance documentation before an audit or submission, Evidence Books automatically collect and organize evidence as AI systems operate. Each Evidence Book contains:
- Pre-configured templates mapped to specific regulatory requirements
- Audit trail exports with cryptographic integrity verification
- Evidence schemas that map system activities to regulatory controls
- Export formats compatible with regulatory submission workflows
- Gap analysis identifying missing evidence before submission
BioCompute Connection
Evidence Books are BioCompute's output layer — the deliverable that turns continuous AI governance into submission-ready compliance packages across six regulatory frameworks.