🔐 Security Overview

Masetra implements a comprehensive security framework designed to protect sensitive pharmaceutical data while maintaining regulatory compliance. Our security approach follows industry best practices and meets the stringent requirements of the pharmaceutical industry.

🛡️ Security Architecture

Defense in Depth Strategy

Masetra employs a multi-layered security approach:

Perimeter Security

  • Firewall Protection: Network-level access control
  • DDoS Protection: Distributed Denial of Service mitigation
  • Intrusion Detection: Real-time threat monitoring
  • Network Segmentation: Isolated network zones

Application Security

  • Secure Coding Practices: OWASP-compliant development
  • Input Validation: Comprehensive data validation
  • Authentication Security: Multi-factor authentication
  • Authorization Controls: Role-based access control

Data Security

  • Encryption: AES-256 encryption at rest and in transit
  • Data Masking: Sensitive data protection
  • Access Logging: Comprehensive audit trails
  • Backup Security: Encrypted backup storage

Zero Trust Security Model

  • Never Trust, Always Verify: Continuous authentication
  • Least Privilege: Minimal necessary access rights
  • Micro-segmentation: Fine-grained network controls
  • Continuous Monitoring: Real-time security assessment

🔑 Identity and Access Management

Authentication Systems

Multi-Factor Authentication (MFA)

  • Something You Know: Password authentication
  • Something You Have: Hardware/software tokens
  • Something You Are: Biometric authentication
  • Adaptive Authentication: Risk-based authentication

Single Sign-On (SSO)

  • SAML 2.0: Security Assertion Markup Language support
  • OAuth 2.0: Industry-standard authorization framework
  • OpenID Connect: Modern authentication protocol
  • Enterprise Integration: Active Directory/LDAP integration

Authorization Framework

Role-Based Access Control (RBAC)

Default Roles

  • System Administrator: Full system access
  • Quality Manager: Quality system oversight
  • Department Head: Department-level management
  • Quality Specialist: Quality process execution
  • Standard User: Basic operational access
  • Viewer: Read-only access

Custom Roles

  • Permission Templates: Pre-defined permission sets
  • Role Hierarchies: Inheritance and escalation rules
  • Dynamic Permissions: Context-aware access control
  • Time-based Access: Scheduled access restrictions

Session Management

  • Secure Sessions: Encrypted session tokens
  • Session Timeout: Automatic session expiration
  • Concurrent Sessions: Session limit controls
  • Session Monitoring: Real-time session tracking

🔒 Data Protection

Encryption Standards

Advanced Encryption Standard (AES-256)

Data at Rest

  • Database Encryption: Transparent data encryption
  • File Encryption: Encrypted file storage
  • Backup Encryption: Encrypted backup files
  • Key Management: Hardware Security Module (HSM)

Data in Transit

  • TLS 1.3: Transport Layer Security
  • Certificate Management: Automated certificate renewal
  • Perfect Forward Secrecy: Session key isolation
  • Certificate Pinning: Certificate validation

Data Integrity

Ensuring Data Authenticity and Consistency

Hash Functions

  • SHA-256: Secure hash algorithm for data integrity
  • Digital Signatures: Cryptographic signature verification
  • Checksum Validation: Data corruption detection
  • Blockchain Integration: Immutable record chains (optional)

Audit Trails

  • Immutable Logs: Non-modifiable audit records
  • Chain of Custody: Complete data handling history
  • Timestamp Authority: Trusted timestamping
  • Digital Signatures: Audit trail authenticity

Data Privacy

Protecting Sensitive Information

Data Classification

  • Public Data: Non-sensitive information
  • Internal Data: Organization-internal information
  • Confidential Data: Sensitive business information
  • Restricted Data: Highly sensitive personal/health data

Privacy Controls

  • Data Masking: Obfuscation of sensitive data
  • Pseudonymization: Data anonymization techniques
  • Consent Management: User consent tracking
  • Data Minimization: Collection of only necessary data

🕵️ Threat Detection and Response

Security Monitoring

Continuous Security Surveillance

Intrusion Detection System (IDS)

  • Network-based IDS: Network traffic analysis
  • Host-based IDS: System-level monitoring
  • Behavioral Analysis: Anomaly detection
  • Signature-based Detection: Known threat identification

Security Information and Event Management (SIEM)

  • Log Aggregation: Centralized log collection
  • Real-time Analysis: Live threat detection
  • Correlation Engine: Cross-system threat correlation
  • Incident Response: Automated response workflows

Vulnerability Management

Proactive Security Assessment

Automated Scanning

  • Static Analysis: Code vulnerability scanning
  • Dynamic Analysis: Runtime vulnerability testing
  • Dependency Scanning: Third-party library vulnerabilities
  • Configuration Auditing: Security configuration review

Penetration Testing

  • External Testing: Third-party security assessment
  • Internal Testing: Internal security evaluation
  • Social Engineering: Human factor testing
  • Red Team Exercises: Advanced threat simulation

Incident Response

Rapid Security Incident Handling

Incident Response Plan

  • Detection: Threat identification and classification
  • Analysis: Impact assessment and threat analysis
  • Containment: Threat isolation and damage limitation
  • Eradication: Threat removal and system cleanup
  • Recovery: System restoration and validation
  • Lessons Learned: Post-incident analysis and improvement

Response Team

  • Security Operations Center (SOC): 24/7 monitoring team
  • Incident Response Team: Specialized response personnel
  • Communication Plan: Stakeholder notification procedures
  • Escalation Procedures: Management escalation protocols

🛠️ Security Operations

Access Control

Granular Access Management

Network Access Control

  • Firewall Rules: Port and protocol restrictions
  • VPN Access: Secure remote access
  • Network Segmentation: Isolated network zones
  • Device Control: Authorized device management

Application Access Control

  • API Security: Rate limiting and authentication
  • User Interface Security: Input validation and sanitization
  • Database Access: Role-based database permissions
  • File System Security: Directory and file permissions

Security Testing

Comprehensive Security Validation

Development Security

  • Code Reviews: Manual security code review
  • Automated Testing: Continuous security testing
  • Security Training: Developer security education
  • Threat Modeling: Proactive threat identification

Production Security

  • Security Audits: Regular security assessments
  • Compliance Testing: Regulatory compliance verification
  • Performance Security: Security impact assessment
  • Third-party Assessment: Vendor security evaluation

Business Continuity

Ensuring System Availability and Resilience

Disaster Recovery

  • Backup Strategy: Regular automated backups
  • Recovery Testing: Periodic recovery testing
  • Geographic Redundancy: Multi-region deployment
  • Recovery Time Objectives: Defined recovery targets

High Availability

  • Load Balancing: Traffic distribution and failover
  • Redundant Systems: Duplicate critical components
  • Automatic Failover: Seamless system switching
  • Performance Monitoring: Real-time system health

🔍 Compliance and Governance

Regulatory Compliance

Meeting Industry Security Standards

FDA 21 CFR Part 11

  • Electronic Signatures: Compliant signature system
  • Audit Trails: Comprehensive activity logging
  • System Validation: Computer system validation
  • Data Integrity: Secure data handling

ISO 27001

  • Information Security Management: ISMS implementation
  • Risk Assessment: Regular security risk evaluation
  • Security Controls: Implemented security measures
  • Continuous Improvement: Ongoing security enhancement

GDPR

  • Data Protection: Personal data security
  • Privacy Rights: Data subject rights fulfillment
  • Breach Notification: Timely breach reporting
  • Data Processing: Lawful data processing

Security Policies

Organizational Security Governance

Policy Framework

  • Acceptable Use: System usage guidelines
  • Password Policy: Password complexity requirements
  • Remote Access: Secure remote work policies
  • Incident Response: Security incident procedures

Training and Awareness

  • Security Training: Regular security education
  • Phishing Awareness: Social engineering protection
  • Role-based Training: Position-specific security training
  • Certification Programs: Professional security certifications

📊 Security Metrics and Reporting

Key Performance Indicators

Measuring Security Effectiveness

Security Metrics

  • Vulnerability Count: Identified security vulnerabilities
  • Patch Compliance: System update compliance rate
  • Incident Response Time: Security incident resolution time
  • Access Violations: Unauthorized access attempts
  • Security Training Completion: Employee training completion

Compliance Metrics

  • Audit Results: Internal and external audit scores
  • Regulatory Compliance: Compliance status tracking
  • Penetration Test Results: Security assessment outcomes
  • Risk Assessment Scores: Current risk profile

Reporting and Dashboards

Real-time Security Visibility

Executive Dashboard

  • Security Score: Overall security health indicator
  • Risk Level: Current security risk assessment
  • Incident Summary: Recent security incidents
  • Compliance Status: Regulatory compliance status

Technical Dashboard

  • System Health: Infrastructure security status
  • Threat Intelligence: Current threat landscape
  • Vulnerability Trends: Security vulnerability trends
  • Access Patterns: User access behavior analysis

🛡️ Security Certifications and Standards

Industry Certifications

Third-party Security Validation

Cloud Security

  • SOC 2 Type II: Security, availability, and confidentiality
  • ISO 27001: Information security management
  • PCI DSS: Payment card industry compliance
  • HIPAA: Healthcare information protection

Development Standards

  • OWASP ASVS: Application security verification
  • NIST Cybersecurity Framework: US cybersecurity standards
  • CIS Controls: Critical security controls
  • CSA Security Guidance: Cloud security best practices

📞 Support

For security questions, contact info@masetra.com or call +256-760-927180.


Last updated: July 30, 2025