21 CFR Part 11 electronic records
FDA 21 CFR Part 11 requires "computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records". AI-assisted record creation falls in scope. Receipts: signed, time-stamped, attribution-linked to operator human_id. Direct mapping to Part 11.10(e) audit-trail requirements.
EMA Annex 11 computerised systems
EMA Annex 11 covers computerised systems in GMP. AI in production validates as a computerised system; receipts evidence the operational audit trail. §9 (audit trails) and §12 (security) are satisfied by signed receipt chain + per-receipt access control.
EU AI Act for medical-device-AI
AI-as-medical-device is high-risk under EU AI Act Annex III. Articles 9-15 obligations apply: risk management, data governance, technical documentation, record-keeping (§12 — receipts!), transparency. The receipt layer satisfies §12 record-keeping directly; the rest of the obligations live in your QMS but feed off the same data.
GxP-aware audit retention
Regulated biotech needs receipt retention measured in years (often 10-25+ depending on indication). Enterprise tier supports custom retention policies + immutable cold storage + audit-time retrieval. The receipt chain remains verifiable across decades.
Operational scenario: AI-assisted protein design
AI helps design candidate proteins. Each design session is a receipt — researcher, project, model, inputs (digest), outputs (digest). When a candidate becomes a clinical trial molecule, the receipt chain traces the AI involvement back to its origin. Patent + IP defence + regulatory traceability all served by the same audit trail.
Operational scenario: clinical trial document drafting
AI assists CSR / protocol drafting. Each AI-assisted section is a receipt — drafter, model, section, supervising medical writer. The audit trail supports ICH E6 GCP record-keeping requirements + satisfies regulatory submissions' growing AI-disclosure expectations.