RWEOne Completes Annual GxP and 21 CFR Part 11 Platform Revalidation Audit

Zero-finding result across 142 controls — including the RabbitMQ-based audit trail fabric, access governance, change control, and AI model validation — confirms the platform's continuing regulatory readiness.

FOR IMMEDIATE RELEASE

Boston — May 5, 2026 — RWEOne today announced the successful completion of its annual third-party GxP and 21 CFR Part 11 platform revalidation audit. The audit, conducted by an independent GxP compliance firm, evaluated 142 controls spanning security, access governance, change management, software validation, audit trail integrity, disaster recovery, and AI model lifecycle governance.

Key Audit Outcomes

• Zero findings across all 142 audited controls
• RabbitMQ-based immutable audit trail fabric validated for integrity, chronological correctness, and non-repudiation
• AI validation engine v3 and v4 model lifecycle governance reconfirmed for Part 11 applicability
• Business continuity and disaster recovery plan tested and revalidated with RTO and RPO targets met
• Physical, logical, and organizational access controls revalidated across all three production regions

CTO Statement

A zero-finding revalidation is the result of more than a decade of treating compliance as an architecture principle rather than a checklist. Every feature we ship — from AI models to a UI button — is designed, built, tested, and documented with the Part 11 inspector in the room.

Media Contact:
RWEOne Press Office
[email protected]