Designed with full user responsibility
• Role-based permissions define what each user can operate, modify, or access
• Structurally prevent shared accounts; each interaction requires unique credentials
Validated system control
• Once activated, compliance mode is irreversible; SSH and Jupyter access are permanently disabled
• Only administrators can modify system configuration or security policies
Security audit trail
• Each run automatically records who performed the action, what was run and when it was run
• Records are cryptographically signed and tamper-proof
• Logs are kept intact and available for FDA inspection at any time
Electronic record integrity
• Each record is associated with the individual who created or approved it
• Records cannot be copied, transferred or modified
• All records remain readable and retrievable for FDA inspection throughout the retention period
