Security & Compliance
Built for the Regulatory Gold Standard.
FDA 21 CFR Part 11 compliant. EU AI Act High-Risk Category ready. GxP validated. Immutable audit trails with cryptographic integrity. Human-in-the-loop governance at every step.
Private AI Infrastructure
Sovereign Infrastructure: Your Intelligence, Your Firewall.
Kuberex is a platform, not a service. We provide the engines; you own the fuel (data) and the output (IP). Complete sovereignty over your pharmaceutical intelligence.
Air-Gapped Options
Fully disconnected environments for sensitive IP. Zero network exposure for your most confidential research data and proprietary algorithms.
Zero External Dependencies
No data ever leaves your VPC (Virtual Private Cloud). All model inference, vector storage, and agent orchestration runs entirely within your perimeter.
BYOK (Bring Your Own Keys)
Complete encryption control for all training datasets and agent memory. Your HSMs, your key rotation policies, your cryptographic sovereignty.
Framework
Compliance architecture for pharmaceutical R&D.
21 CFR Part 11
Electronic Records & Signatures
AI Act Ready
High-Risk AI Category Compliance
Audit & Traceability
Immutable Audit Trails: The Regulatory Gold Standard
Every agent action is logged, timestamped, and cryptographically secured. When regulators ask "why?", you have a complete, verifiable answer with one-click source attribution.
Cryptographic Hashing
Every agent decision is SHA-256 hashed and timestamped. Chain integrity verified continuously.
Source Attribution
One-click "Back-to-Source" shows exactly which lab notebook, CSV, or document a claim was derived from.
GxP Compliance Ready
21 CFR Part 11 and EU AI Act (High-Risk Category) compliant audit infrastructure out of the box.
Module 2.5 Clinical Overview - Draft v1.2
Compliance: 99.2% | Refs: 847/847 verified
Hash: sha256:7a2f9b4e8c1d...c3d8f2a1
Safety signal flagged in Section 2.5.5
Assigned: m.jones@pharma.com (QA Lead)
Record locked for regulatory submission
E-Signature: m.jones@pharma.com | 21 CFR Part 11 Compliant
Governance Dashboard
Human-in-the-Loop Command Chain
Every agent output follows a strict governance protocol. No autonomous decisions reach production without expert verification.
Agent Processing
Agent synthesizes data within your sandbox. All processing occurs in isolated environment.
Human Review
Expert identifies potential hallucinations or data anomalies. Configurable trigger thresholds.
QA Approval
Quality Assurance signs off on the audit-ready output. E-signature captured.
Final Output
Immutable record generated for regulatory submission. Full chain of custody preserved.
Configurable triggers determine when human review is required—from safety signals to regulatory threshold crossings.
Get Started
See SINA + Kuberex in Action
Start a 30-day pilot and experience first-hand how SINA and the Kuberex Shield meet your regulatory requirements—deployed entirely in your private cloud.