Regulatory-Grade Platform
oriGENapi meets the strictest compliance standards for pharmaceutical, supplement, and healthcare organizations. FDA, GMP, HIPAA, SOC 2 certified.
Trusted by Regulated Industries
We maintain certifications across FDA compliance, security, and quality management.
FDA Compliance
Full FDA 21 CFR Part 11 compliance for electronic records and signatures
Our platform meets all FDA requirements for GMP supplement compliance, cGMP regulations, and documentation standards required for pharmaceutical operations.
GMP Certified
Good Manufacturing Practices verification and monitoring
Automated GMP supplier verification, facility audits, and compliance status tracking. Real-time alerts for any GMP violations or audit findings.
ISO 9001:2015
Quality Management System certification
ISO 9001:2015 certified operations ensuring consistent quality across all processes, document control, and continuous improvement protocols.
SOC 2 Type II
Security and availability audit attestation
Annual SOC 2 Type II audits confirm security controls, system availability, and data processing integrity. Detailed audit reports available upon request.
HIPAA Ready
Health Insurance Portability and Accountability Act readiness
HIPAA-compliant infrastructure with BAA agreements available for organizations handling patient data and protected health information.
GDPR & Data Privacy
General Data Protection Regulation compliance
Full GDPR compliance with data residency options, privacy policies, DPA agreements, and user consent mechanisms for EU operations.
Built-In Regulatory Support
Audit Trail & Documentation
- •Complete digital audit trail of all transactions and decisions
- •Timestamped records with user attribution
- •Immutable record storage for FDA and regulatory submissions
- •Export-ready documentation for audits and inspections
Supplier Compliance Monitoring
- •Real-time FDA warning letter and recall monitoring
- •Automated GMP facility status verification
- •Compliance score tracking and alerts
- •Supplier certification management and renewal tracking
Data Security & Integrity
- •Encrypted data transmission (TLS 1.2+)
- •Encrypted storage (AES-256)
- •Role-based access control (RBAC)
- •Two-factor authentication and single sign-on
Regulatory Reporting
- •Automated compliance reports for regulators
- •Quality metrics and KPI dashboards
- •Traceability and chain-of-custody documentation
- •Custom report generation for audits
Frequently Asked Questions
Get answers to common compliance and security questions.
FDA & Regulatory
Data Security & Privacy
Implementation & Deployment
Your Data Protection
Comprehensive security policies and incident response procedures protect your sensitive information.
Data Residency & Sovereignty
- Choose US, EU, or custom data center locations
- Full compliance with data localization requirements
- Encrypted cross-region replication
- No data transfer without explicit consent
Incident Response
- 24/7 security monitoring and alerting
- Incident response team on standby
- Communication plan within 4 hours of incident
- Post-incident analysis and remediation
Compliance Certifications
- Annual third-party security audits
- ISO 27001 information security management
- Regular penetration testing and code reviews
- Bug bounty program for external researchers
Access & Authentication
- Multi-factor authentication (MFA)
- Role-based access control (RBAC)
- Single sign-on (SSO) integration
- Session management and audit logging
Easy Compliance Verification
We provide everything needed to pass your vendor security assessments.
Compliance Documentation
- SOC 2 Type II Report
- ISO 27001 Certificate
- HIPAA BAA
- DPA Agreement
Security Questionnaires
- CAIQ (Cloud Security)
- ISA 3623
- AICPA TSC
- Custom Assessments
Technical Details
- Architecture Diagrams
- Encryption Details
- Uptime SLA
- Disaster Recovery Plan
Ready to Pass Your Compliance Audit?
Our compliance team can provide all documentation and support needed for your vendor assessments and regulatory submissions.