Regulatory Reporting
E2B(R2/R3) generation, CIOMS reports, and regulatory submission management
21 CFR Part 11 Compliant
Submission Queue
| Submission ID | Type | Region | Case | Status | Deadline | ACK | Actions |
|---|---|---|---|---|---|---|---|
| SUB-2024-0891 | E2B(R3) | FDA | CASE-2024-1847 | Submitted | 2024-01-20 | ACK-001 | |
| SUB-2024-0890 | CIOMS I | EMA | CASE-2024-1843 | Pending Review | 2024-01-19 | — | |
| SUB-2024-0889 | E2B(R2) | PMDA | CASE-2024-1839 | Draft | 2024-01-22 | — | |
| SUB-2024-0888 | E2B(R3) | MHRA | CASE-2024-1835 | Submitted | 2024-01-17 | ACK-004 | |
| SUB-2024-0887 | CIOMS I | FDA | CASE-2024-1830 | Overdue | 2024-01-14OVERDUE | — |
Submission Audit Trail — SUB-2024-0891
2024-01-15 14:32:01SystemACK received from FDA FAERS
2024-01-15 14:30:45SystemE2B(R3) XML submitted via AS2 gateway
2024-01-15 14:28:12Dr. JohnsonApproved submission — e-signature applied
2024-01-15 14:25:00AI AgentE2B(R3) XML generated and validated
2024-01-14 09:15:33QC AgentQuality control validation passed