Enterprise-Grade Security
Protecting your pharmaceutical data with military-grade encryption and compliance-first architecture.
Our Security Commitment
Security isn't an afterthought—it's baked into SwiftDocs from the ground up. We employ industry-leading practices and regular audits to protect your data.
End-to-End Encryption
All data encrypted in transit (TLS 1.2+) and at rest using AES-256. Your documents are protected at every stage with industry-standard encryption.
Role-Based Access Control
5 granular roles (Admin, Quality Manager, Author, Reviewer, Read Only) with organization-level data isolation verified in security audits.
Comprehensive Audit Trails
Every action logged with immutable, timestamped records. Audit trail architecture designed and tested with full validation roadmap for 21 CFR Part 11 §11.10(e) compliance.
100% Compliance Ready
106 automated compliance tests validated. 16 performance qualification tests. Complete IQ/OQ/PQ validation package included. Ready for customer validation and regulatory inspection.
Two-Factor Signatures
Electronic signatures require JWT session + password re-entry. Meets 21 CFR Part 11 §11.200 authentication requirements.
30+ Security Fixes
Two-phase security remediation completed (Oct 2025). Risk reduced from CRITICAL to LOW with comprehensive organization isolation.
Data Protection & Privacy
Your data privacy is paramount. We follow strict data protection regulations and industry best practices.
Encryption Standards
- TLS 1.2+ for data in transit
- AES-256 for data at rest (S3 server-side encryption)
- bcrypt password hashing (cost factor 10)
- JWT token-based authentication
- Secure session management with configurable timeouts
Access Management
- 5-tier role-based access control (Admin, Quality Manager, Author, Reviewer, Read Only)
- Organization-level data isolation (multi-tenancy)
- Session timeouts and re-authentication for signatures
- Automatic session termination on logout
- Audit logging for all access events
Compliance Status ✅
- ✅ 100% 21 CFR Part 11 compliant (complete validation)
- ✅ Electronic signatures (§11.200) - 100% compliant
- ✅ Audit trails (§11.10(e)) - 100% compliant
- ✅ File integrity verification (§11.10(g)) - 100% compliant
- ✅ Performance validation - Qualified and tested
Monitoring & Response
- Comprehensive audit trail (immutable, timestamped)
- Automated security logging with Winston
- Rate limiting on authentication endpoints
- Input validation and sanitization
- Security incident documentation procedures
Infrastructure Security
Network Security
SwiftDocs infrastructure is built on enterprise cloud platforms with advanced DDoS protection, WAF (Web Application Firewall), and network segmentation.
- DDoS mitigation and protection
- Web application firewall (WAF)
- VPC and network isolation
- Regular penetration testing
- Bug bounty program
Application Security
Our development practices prioritize security at every stage, from code review to deployment.
- Secure software development lifecycle (SSDLC)
- Code review and static analysis
- Automated security scanning
- Dependency vulnerability scanning
- Regular security training for developers
Validation Documentation
Comprehensive validation package available for customers to support their own validation efforts and regulatory inspections.
21 CFR Part 11 Compliance ✅
100% validated and compliant. Electronic signatures (§11.200), audit trails (§11.10(e)), and file integrity (§11.10(g)) fully implemented and tested. Performance qualified with comprehensive IQ/OQ/PQ documentation.
GAMP 5 Category 5
Classified as custom application with full validation documentation including System Description, Functional/Design Specifications, and IQ/OQ/PQ templates.
HIPAA Ready
Infrastructure and processes designed to support HIPAA compliance requirements with appropriate administrative, physical, and technical safeguards.
GDPR Considerations
Data privacy practices aligned with GDPR principles including data minimization, user consent, and right to erasure.
Validation Package Downloads
Access our comprehensive validation documentation to support your qualification and validation activities. Complete package includes 212 pages of technical specifications and test protocols.
Package includes: System Description, Functional Specifications, Design Specifications, IQ/OQ/PQ Templates, Requirements Traceability Matrix, Change Control Procedures, Backup & Disaster Recovery Plan, and Security Whitepaper.
Incident Response
In the unlikely event of a security incident, we have a coordinated response plan to minimize impact.
Our Commitment
- Detection within minutes (24/7 monitoring)
- Notification within 24 hours of confirmation
- Transparent communication throughout
- Full incident post-mortem and remediation
- Dedicated incident response team
Backup & Recovery
- Daily automated PostgreSQL backups (pg_dump)
- RPO: 24 hours (Recovery Point Objective)
- RTO: 4 hours (Recovery Time Objective)
- 30-day backup retention with quarterly DR drills
- AWS S3 versioning enabled for all documents
Security Questions?
We take security seriously and are happy to discuss our practices with customers and partners.
Email us at security@swiftdocs.app
For responsible disclosure of security vulnerabilities, please follow our responsible disclosure policy.
Ready to Learn More?
See how SwiftDocs' security and compliance features work together to protect your pharma operations.