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COMPLIANCE & SECURITY

Built for Regulated Environments

oriGENapi is designed from the ground up to meet the strictest regulatory and security requirements in pharmaceutical and biotech.

Certifications & Standards

We maintain the certifications and compliance standards your organization requires.

FDA 21 CFR Part 11

Full compliance with electronic records and electronic signatures requirements. Audit trails, access controls, and data integrity validation.

SOC 2 Type II

Independent third-party audit confirming our security controls for data protection, availability, processing integrity, and confidentiality.

GMP Certified

Our platform and supplier network adhere to Good Manufacturing Practice standards. Regular facility audits and quality system assessments.

HIPAA Compliant

Protected health information is handled with the highest standards. BAA agreements, encryption, access controls, and breach notification procedures.

ISO 27001

Information security management system certified to international standards. Risk assessment, security controls, and continuous monitoring.

ICH Q7 Aligned

API manufacturing and distribution aligned with International Council for Harmonisation guidelines for active pharmaceutical ingredients.

Compliance Framework

A layered approach to security and compliance, from data protection to regulatory reporting.

Security & Compliance Stack

Data Security
End-to-end encryption, at-rest protection, and secure key management
LAYER 1
Access Controls
Role-based permissions, SSO integration, and multi-factor authentication
LAYER 2
Audit Trails
Immutable logs for every action, data change, and system event
LAYER 3
Regulatory Reporting
Automated compliance reports for FDA, EMA, and global authorities
LAYER 4
0%
Audit Pass Rate
0
Data Breaches
0/7
Monitoring
0%
Uptime

Our Compliance Promises

Commitments we make to every customer, every day.

Data Sovereignty

Your data remains in the region you choose. We support deployments across US, EU, and Asia-Pacific with full data residency controls.

Zero-Trust Architecture

Every request is authenticated and authorized. No implicit trust, no exceptions. We verify every interaction across every layer.

Continuous Compliance

We don't just pass audits, we live compliance daily. Automated checks, real-time monitoring, and proactive remediation keep us ahead.

Frequently Asked Questions

Common questions about our compliance and security practices.

TRUSTED BY REGULATED INDUSTRIES

FDA 21 CFR Part 11
GMP Certified
ISO 27001
SOC 2 Type II
HIPAA Compliant
ICH Q7 Aligned

Questions About Compliance?

Our compliance team is available to discuss your specific regulatory requirements and provide detailed documentation.

Contact Compliance Team