Validation

This topic provides an overview of the features and functions of Validator

The Validation tab of the Validator application is equipped with features that help you to validate electronic

Common Technical Document (eCTD) submissions and non-eCTD electronic submissions (NeeS) created by any software application. You can also verify the conformity of the CTD structure by performing a variety of validations to confirm that the submission is complete and accurate following ICH and regional requirements and specifications, prior to sending it to the agency.

The Validation tab includes the following features and functions:

— Intuitive graphical user interface

— Ability to copy applications from physical media to review area

— Ability to validate eCTD XML file(s) against eCTD DTD provided

— Validation of the regional XML files(s) against the corresponding regional DTD provided

— Validation of folders provided against XML references

— Validation that the files provided are all referenced in the regional and backbone XML files

— Validation that the relevant submission folder contains one and only one eCTD XML file

— Validation that the relevant submission folder contains only one XML file for a given region — Ability to Add/Remove validation criteria selection — Support for NeeS submissions