MANAGE-DATA-1ACQUIRE-DATA-1ANALYZE-DATA-1ACCESS-DATA-1PROTECT DATA

 

Full end to end traceability and auditability to minimize human error and ensure compliance

Throughout the full medical imaging and data flow, our platform facilitates end to end traceability and auditability, following higher industry standards such as HIPAA, GDPR, and FDA Title 21 CFR Part 11. Several features help the investigator and/or sponsor to be GxP compliant.

Electronic

Electronic Signatures

  • Permitted users can access detailed audit trails
  • Use and review electronic signatures, and approval workflows ensure tracking and authorization
  • Create, view, respond to Queries throughout the study
Audit Trails

Comprehensive Audit Trails

  • All entered data and changes are saved (audit trail, data trail and edit trail)
  • Individuals who are authorized to make data changes is restricted and user rights alterations are logged
Backup

Backup & Restore

  • Data are backed up and can be retrieved
  • Disaster recovery support
Access-Control

Access Control

  • unauthorized access to the data is prevented with a security system
  • Two-factor authentication
Secure Data

Secure Data Storage

  • Encrypted data at rest
  • Seamless data location for storage and support, federated jurisdictions

MANAGE-DATA-1ACQUIRE-DATA-1ANALYZE-DATA-1ACCESS-DATA-1PROTECT DATA

 

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