The Safety Database is a comprehensive platform developed in full compliance with the ICH E2B(R3) standard. It enables the entire life cycle of a case to be managed in a single system — from the initial report of an adverse event to medical assessment, from follow-up processes to reporting to regulatory authorities (TİTCK, EMA, FDA).
Key features of the platform:
- Role-based, multi-user support
- Case entry and data management
- Seriousness assessment
- Management of follow-up processes
- MedDRA coding support
- Outputs for electronic submission to regulatory authorities (PDF BOGR, PDF CIOMS, XML)
- ICH E2B (R3) compliant XML export
- Import of ICH E2B (R3) compliant XML into the platform
- Comprehensive audit trail
- Electronic signature support
- Computerized system validation support
The platform has been validated in accordance with GxP requirements and is fully compliant with FDA 21 CFR Part 11.