NoxReg Trust & Compliance

How NoxReg is designed to support your GxP obligations

AI Transparency (EU AI Act Article 50)

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

🤖 Every AI-generated output in NoxReg emails and dashboard views carries a visible disclaimer and must be reviewed by a qualified regulatory professional before use in any regulated activity.

Data Processing

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 data 2 years post-cancellation, AI logs 5 years.

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.

GVP Module I Support

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

Remediation Status

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	🔄 Q3 2026
Full CSV validation pack	MAJOR	🔄 Q3 2026

Documentation Requests

✉ Request Data Processing Agreement (DPA)✉ Request PSMF System Description ✉ Request Vendor Audit Pack

NoxReg — Pharmaceutical Regulatory Intelligence · security@noxreg.com