Trust & Security
BioWise is built from the ground up with pharmaceutical-grade security. Your compliance data is protected by enterprise-level controls, certifications, and continuous monitoring.
Certifications & Compliance
Independent audits and certifications validate our security controls.
SOC 2 Type II
Annual third-party audit of security, availability, and confidentiality controls.
ISO 27001
International standard for information security management systems (ISMS).
HIPAA
Compliant with healthcare data protection requirements where applicable.
GDPR
Full compliance with EU data protection regulations and privacy rights.
Security Features
Data Encryption
All data is encrypted at rest (AES-256) and in transit (TLS 1.3). Encryption keys are managed via AWS KMS with automatic rotation.
- - AES-256 at rest
- - TLS 1.3 in transit
- - Key rotation every 90 days
Penetration Testing
Regular third-party penetration testing by certified security firms. All findings are tracked and remediated within SLA.
- - Annual full-scope pentest
- - Quarterly vulnerability scans
- - Bug bounty program
Access Control
Role-based access control with principle of least privilege. SSO integration with your identity provider.
- - SAML 2.0 / OIDC SSO
- - Multi-factor authentication
- - Session management
Audit Logging
Comprehensive audit logs of all user actions and system events. Immutable log storage for compliance requirements.
- - Complete action history
- - Tamper-evident storage
- - 7-year retention
Data Isolation
Multi-tenant architecture with strict logical data isolation. Customer data is never commingled.
- - Tenant-level encryption
- - Isolated databases
- - Network segmentation
Incident Response
24/7 security monitoring with defined incident response procedures. Customers notified within 24 hours of any incident.
- - 24/7 SOC monitoring
- - Incident response plan
- - Customer notification SLA
Infrastructure Security
Cloud Infrastructure
- Hosted on AWS with SOC 2 and ISO 27001 certified data centers
- Multi-AZ deployment for high availability
- Regional data residency options (US, EU, APAC)
- Automated backups with point-in-time recovery
Network Security
- Web Application Firewall (WAF) protection
- DDoS protection via AWS Shield
- Private VPC with network segmentation
- VPN/Private Link options for integrations
Pharmaceutical Regulatory Compliance
BioWise is designed to meet pharmaceutical industry regulatory requirements.
21 CFR Part 11
Compliant electronic records and signatures with complete audit trails, access controls, and data integrity controls.
Annex 11
Computerized systems requirements for European market access including data integrity and system validation support.
Validation Ready
Risk-based validation approach with IQ/OQ/PQ documentation templates and support for your validation activities.
Request Security Documentation
Need our SOC 2 report, penetration test summary, or security questionnaire? Contact our security team.
Security questions?
Our security team is ready to discuss your requirements and provide documentation.
Schedule Security Review