eCTD Generator Highlights
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Easy dossier compilation Adding files to the submission is made easy by drag-and-drop. To simplify reuse of information, source documents are uniquely stored in the central repository and are only linked to the submission folder during the submission setup phase. Consistency and integrity checks An integrated conformity checker ensures compliance of the XML to ICH and regional schemas. A built-in validation system checks for errors and outdated or missing files before submission creation. Maximum consistency is ensured by the version check tool integrated in the system. It checks for outdated or orphaned elements in the submission and automatically proposes to delete/update them. With eCTD Generator your submissions are always accurate and up-to-date. Easy sequence creation |
Lifecycle management A key feature of the tool is lifecycle management. New sequences are created as related or unrelated to earlier submissions. You can add,append or replace new elements, as well as exclude existing ones from the new sequence. All changes are reversible to restore the previous state. Automated XML backbone generation An XML backbone file is a primary technical component of an eCTD submission. eCTD Generator enables an effortless automatic creation of the XML backbone and Study Tagging Files in the background and stores the results in the defined location. Full lifecycle management |