Safety Case Transformation & Reconciliation
Save Time and Improve Quality
A scalable and repeatable way to transform safety case data into E2B R2 Files and automate safety data reconciliation
Smart E2B R2 File Generation
- Aggregation & Transformation of EDC & Other Source data structures into E2B R2 XML structure
- Option to conditionally merge related events to create a combined safety case
- Auto convert EDC code lists and measurement units to align with the Safety Database’s standardized values
Automatic System to System Reconciliation
- Outbound write to SFTP to transmit (and reconciliation transmission) between systems
- Reporting capability to identify data changes to safety cases to support safety case processing
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