Data Protection
GDPR-compliant data processing pipelines with options for regional hosting and data residency.
Compliance Framework
Designed for Regulated Healthcare
Built to survive due diligence in pharma, biotech, and clinical settings. End-to-end encryption, multi-tenant safety barriers, and complete audit-ready traceability.
GDPR
GxP Ready
HIPAA Compliant
SOC2 Type II
Audit Log System
Immutable Security Events
TLS 1.3 Ingest - raw text parsed
Case ID: #EP-4029 · Encrypted
Secured
MedDRA parsing - mapped 2 PT codes
Symptoms: dizziness postural, headache
Mapped
Specialist sign-off verified
User ID: #MA-4029 (S. Jenkins, MD)
Approved
E2B XML database sync initiated
Destination: Argus Safety Vault
Synced
Enterprise Security
Regulated Compliance Controls
Ensuring compliance is not an option in pharma; it is a structural pillar. Every feature in RxGenius conforms to regulatory constraints.
Built for GxP environments
The platform follows software validation principles under GxP rules. Our design process matches standard software development lifecycles (SDLC) required for life sciences, including detailed testing logs, backup routines, and verification pipelines.
Anonymized Patient Data Shield
For clinical trial modules and e-pharmacy integrations, patient names and personally identifiable information (PII) are masked and anonymized at intake. Only safety and clinical findings are processed, preventing sensitive data exposure.
End-to-End Auditability
Every response generated by the Medical Information assistant and every signal validated by a Drug Safety specialist has a clear version trail. You can trace who queried the information, what clinical document was cited, who verified it, and when it was delivered.
Controls
Security Architecture
Our infrastructure matches standard institutional safety requirements to secure health records.
Encryption
Strict AES-256 encryption at rest and TLS 1.3 in transit across all portals, APIs, and sync channels.
Audit Logging
Immutable event logging capturing every system access, response edit, and signal classification.
Oversight Controls
Enforces human reviewer sign-offs before safety reports are generated or responses finalized.
Secure APIs
Role-based token authentication and rate-limiting to secure integrations with external databases.
GxP Compliance
Rigorous validation scripts and testing evidence packages, prepared for your GxP audits.
Ready to close the gap between Medical Information and Drug Safety?
See how RxGenius.ai helps Medical Affairs and Pharmacovigilance teams catch more, work faster, and stay audit-ready — without adding headcount.
Book a Demo