Safety management is turning global and submissions are becoming centralized using E2B specification guidance document. There is a need of automated validation check before these ICSRs are finally sent to regulatory or other affiliates as a part of expedited/periodic submissions or for further quality analysis prior to submissions.
We are in an industry where compromise in quality of data can indeed be a costly yet irreparable affair. Safety data management and the procedure to comply with it necessitates a system in place; a robust system for reports submitted to different regulatory.
System allows validation of E2B XML files to ensure error-free XML submissions to regulatory with respect to both R2 and R3 compliance.