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 data protection, 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 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
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 & Restore
Data are backed up and can be retrieved
Disaster recovery support
Access Control
unauthorized access to the data is prevented with a security system
Two-factor authentication
Secure Data Storage
Encrypted data at rest
Seamless data location for storage and support, federated jurisdictions
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