Enterprise-Grade Security Infrastructure

Built for pharmaceutical manufacturing operations. SOC 2 Type II certified. HIPAA compliant. Designed to meet 21 CFR Part 11 requirements.

SOC 2 TYPE II
HIPAA COMPLIANT
21 CFR PART 11
ISO 27001
Security Framework

Multi-Layered Defense Architecture

Our security infrastructure is purpose-built for pharmaceutical manufacturing environments, protecting sensitive CMC data across distributed systems.

Data Encryption

End-to-end encryption for data in transit and at rest using industry-standard protocols.

  • TLS 1.3 for all network traffic
  • AES-256 encryption at rest
  • Key rotation and HSM integration
  • Field-level encryption for PII/PHI

Access Control

Role-based access control with principle of least privilege and mandatory multi-factor authentication.

  • RBAC with granular permissions
  • MFA enforcement (TOTP, U2F)
  • SSO/SAML 2.0 integration
  • Session management and timeout

Audit & Compliance

Comprehensive audit trails meeting regulatory requirements for pharmaceutical manufacturing.

  • Immutable audit logs
  • 21 CFR Part 11 electronic records
  • Change tracking and versioning
  • Regulatory reporting capabilities

Network Security

Zero-trust network architecture with defense-in-depth strategies.

  • VPC isolation and segmentation
  • DDoS protection and WAF
  • Private connectivity options
  • IP allowlisting and geofencing

Infrastructure Security

Secure-by-design cloud infrastructure with automated threat detection.

  • Container security scanning
  • Automated vulnerability patching
  • Intrusion detection systems
  • Infrastructure as code validation

Data Residency

Flexible data residency options to meet regional compliance requirements.

  • Regional data storage options
  • Data sovereignty compliance
  • Backup and disaster recovery
  • Data retention policies
Regulatory Compliance

Industry Standards & Certifications

Lattïx.AI maintains compliance with industry-leading security standards and pharmaceutical manufacturing regulations.

Standard / Regulation Description Status
SOC 2 Type II Independent audit of security, availability, and confidentiality controls Certified
HIPAA Health Insurance Portability and Accountability Act compliance Certified
21 CFR Part 11 FDA electronic records and electronic signatures requirements Compliant
ISO 27001 Information security management system standard Certified
GDPR General Data Protection Regulation (EU data protection) Compliant
GxP Good Practice quality guidelines for pharmaceutical manufacturing Aligned
ISO 27017 Cloud security controls In Progress
System Architecture

Defense-in-Depth Security Model

Multiple layers of security controls protecting your manufacturing data across every tier.

PERIMETER DEFENSE NETWORK SECURITY APPLICATION LAYER ENCRYPTED DATA AES-256 | Field-Level Encryption WAF DDoS IDS MFA RBAC Audit Logs
Security FAQ

Frequently Asked Questions

Lattïx.AI employs a defense-in-depth security model with multiple layers of protection. All data is encrypted in transit using TLS 1.3 and at rest using AES-256 encryption. We implement strict role-based access controls, multi-factor authentication, and maintain comprehensive audit trails that meet 21 CFR Part 11 requirements. Our infrastructure is SOC 2 Type II certified and undergoes regular third-party security audits.
We offer flexible data residency options to meet your compliance requirements. Data can be stored and processed in your choice of geographic regions including US, EU, and APAC. All data remains within the selected region and we maintain strict data sovereignty policies. Backup and disaster recovery infrastructure is maintained within the same geographic boundaries.
Lattïx Intelligence maintains comprehensive audit trails for all system activities, user actions, and data modifications. Electronic signatures are cryptographically secure and time-stamped. The platform enforces strict access controls, validates user identity through multi-factor authentication, and maintains tamper-evident audit logs. All electronic records include metadata for authorship, timestamps, and change history in accordance with FDA requirements.
We maintain a formal incident response plan with defined escalation procedures. Our security operations center monitors systems 24/7 for potential threats. In the event of a security incident, we follow established protocols including immediate containment, investigation, remediation, and notification procedures that comply with regulatory requirements. Detailed incident reports are provided to affected customers within defined SLA timeframes.
Yes. Lattïx Intelligence supports integration with enterprise identity providers through SAML 2.0 and OAuth 2.0/OIDC. We can integrate with your existing SIEM platforms for centralized security monitoring and support private network connectivity options including VPN, AWS PrivateLink, and Azure Private Link. Our API security follows OAuth 2.0 standards and supports custom authentication requirements.
We conduct annual SOC 2 Type II audits performed by independent third-party auditors. Penetration testing is performed quarterly by certified ethical hackers. Vulnerability scanning and security assessments run continuously on our infrastructure. We also maintain an ongoing internal security review process and participate in responsible disclosure programs with the security research community.

Secure Your Manufacturing Operations

Schedule a security briefing to discuss your compliance requirements and infrastructure security needs.

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