Regulatory Ready
EvidAI produces documentation that meets the stringent requirements of regulatory agencies and health technology assessment bodies.
Regulatory Standards
FDA (United States)
Requirements addressed:
- Complete audit trails
- Reproducible methodology
- Transparent decision-making
- Quality assessment documentation
- Statistical analysis details
EMA (European Union)
Compliance with:
- Scientific advice requirements
- Clinical assessment reports
- Benefit-risk documentation
- Marketing authorization standards
HTA Bodies
Support for:
- NICE (UK): Technology appraisals
- IQWIG (Germany): Benefit assessments
- HAS (France): Medical device reviews
- CADTH (Canada): Drug reviews
- PBAC (Australia): PBS submissions
Documentation Features
Complete Audit Trail
Every action recorded:
- Search execution details
- Screening decisions (all)
- Extraction verification
- Quality assessments
- Synthesis parameters
- Human overrides
Reproducibility Package
Export includes:
- Full search strategies
- Complete decision logs
- Statistical analysis code
- Methodology documentation
Version Control
Track all changes:
- Amendment history
- Protocol deviations
- Update documentation
- Version comparison
Submission Packages
Core Documents
- Protocol with amendments
- Complete methods section
- Full results documentation
- Quality assessment summary
Supporting Materials
- Raw data exports
- Statistical analysis files
- PRISMA documentation
- GRADE evidence profiles
Audit-Ready Files
- Decision audit logs
- Process documentation
- Quality assurance records
- Team contribution logs
Compliance Features
Data Integrity
- Timestamped entries
- User attribution
- Change tracking
- Secure storage
Quality Management
- Process documentation
- Validation records
- Deviation tracking
- CAPA documentation
Access Control
- Role-based permissions
- Action logging
- Review workflows
- Approval tracking
Export Formats
Standard Formats
- Word documents
- PDF packages
- Excel data files
- XML structured data
Agency-Specific
- FDA CTD format
- EMA dossier structure
- HTA body templates
Best Practices
During Review
- Document decisions in real-time
- Follow protocol strictly
- Record all amendments
- Maintain clear attribution
For Submission
- Verify completeness
- Cross-check documentation
- Prepare audit summary
- Include all appendices