XML Validator

Safety management is turning global and submissions are becoming centralized using E2B specification guidance document. There is a need of automated 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

  • PvEdge XML validator validates for:

    • Mandatory fields in XML
    • Character length allowed in XML nodes
    • Notified for un-allowed characters for rectifying the field values
    • EU and FDA region submissions, for differences w.r.t specific nodes
    • Rules as in E2B XML guidance document
    • Errors and warnings as per E2B specifications
    • Study cases as well as post-marketing cases/ICSRs
    • Final check at submission stage to rectify any pending error/warning messages