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The eCTD Manager is delivered to the user over the web, so no software installation is required. Through a rich, yet simple-to-use interface, users can:
- insert files into the eCTD hierarchy from their local drive, or from content stores managed through ALiCE
- preview the content of files instantly
- automatically populate folder contents based on pre-defined criteria
- update an entire eCTD status at the click of a button
- check for submission readiness warnings and errors
The eCTD Manager keeps track of sequence numbers for the eCTD as successive submissions are made. Consequently, the contents of the eCTD can be inspected by sequence number at any time. This gives the user access to the eCTD's entire lifecycle history.
Finally, eCTD Manager comes with an additional ALiCE service, eCTD Publisher. This additional service extends the capabilities of ALiCE by providing a Drug Application Submission publishing solution. Upon publication, the eCTD submission content is exported, file checksum values are computed, the backbone, regional and study tagging xml files are generated and the submission is scanned to ensure that it conforms to regulatory requirements.
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