Product/Service

eCTD Software

Source: MasterControl

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How MasterControl Optimizes eCTD Software Systems to Ensure Quality of the eCTD Submission

How MasterControl Optimizes eCTD Software Systems to Ensure Quality of the eCTD Submission

Companies in regulated environments are now required by the FDA to file their eCTD (electronic common technical document) electonically in the form of an eCTD. In order to optimize their eCTD system, companies need:

1. Automated Document Control / Document Management
2. A secure, Web-based location where access to submissions documents can be easily controlled
3. A optional mechanism or eCTD software for creating copies of approved submission documents in the desired folder structure to share with a submission publishing group or contractor. (This is needed only when companies are not using eCTD software, but instead contracting out this function.)