All content generated by NoxReg's AI (Claude, Anthropic) is clearly labeled as AI-generated. Importance scores, summaries, and action recommendations are starting points for expert review — not regulatory conclusions. Prompt version: v1.2 | Model: Claude Haiku
Subscriber data is processed under GDPR Article 6(1)(b) (contract performance). Regulatory document text processed by AI under Anthropic's standard Data Processing Agreement. Data stored exclusively in EU West (Ireland). Retention: subscriber/account data deleted 90 days post-cancellation; regulatory article data and AI generation logs retained 5 years for audit trail.
NoxReg maintains append-only AI generation logs recording: model version, prompt version, input hash, classification result, and timestamp for every AI invocation. Available to Enterprise subscribers for 21 CFR Part 11 and EU Annex 11 compliance needs.
Pro and Enterprise subscribers receive a PSMF-ready system description document suitable for inclusion in your Pharmacovigilance System Master File per GVP Module I Section I.B.3. Request at: security@noxreg.com
| Finding | Severity | Status |
|---|---|---|
| AI content labeling (EU AI Act Art. 50) | CRITICAL | ✅ Implemented |
| Audit trail logging | CRITICAL | ✅ Implemented |
| PSMF documentation | CRITICAL | ✅ Available on request |
| DPA for subscribers | MAJOR | ✅ Available on request |
| Hallucination warnings | MAJOR | 🔄 In progress |
| Human oversight UI | MAJOR | ✅ Live |
| Full CSV validation pack | MAJOR | 🔄 Q3 2026 |
NoxReg — Pharmaceutical Regulatory Intelligence · security@noxreg.com