Platform
Auditability
The EMAW platform is a fully transparent, ‘white box’ system designed to ensure complete auditability for sponsors, regulatory bodies, and quality assurance teams.
Comprehensive Audit Trail
The platform provides a detailed, end-to-end audit trail covering:
- Platform engineering and configuration
- Rules, flags, and alerts
- AI models and reports
This ensures that all actions and modifications are tracked, logged, and accessible for compliance and validation purposes.
Regulatory Compliance & Global Validation
The EMAW platform meets the highest compliance standards:
GDPR & 21 CFR Part 11 compliant
Validated in global Phase 2 & 3 trials
Role-Based Access & Administration
The platform is rights-based, meaning access and permissions can be managed by:
- Sponsors
- CROs (Contract Research Organizations)
- Clinical trial sites
This ensures controlled, secure access based on user roles while maintaining full auditability and compliance.