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:
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While critical, eCTD software is not enough to ensure a successful eCTD submission. All information in the submission must be controlled, secure, and approved. MasterControl provides the following software for ensuring that, in addition to eCTD software, a company has everything it needs to assure a successful eCTD submission:
Ginny Ventura, Regulatory Information Specialist in the Center for Drug Evaluation and Research, is another eCTD expert. Ventura lists the top 12 issues for eCTD software success as:
For more information about how MasterControl can help with the solutions necessary to ensure that the eCTD software and eCTD system a company is using is optimally successful, please feel free to contact a MasterControl representative.