eCTD Software Systems
Companies in regulated environments are now required by the FDA to file their eCTD (electronic common technical document) electronically in the form of an eCTD. In order to optimize their eCTD system, companies need:
- Automated Document Control / Document Management
- A secure, Web-based location where access to submissions documents can be easily controlled
- An 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.)
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How MasterControl can Help with eCTD Software Systems
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:
- MasterControl Submissions Ready Docs™ is designed for companies that want to implement a complete document management / document control solution in preparation for a regulatory submission. The eCTD software provides submission-related document templates, as well as preconfigured document types specific to a company's submission. Collaboration functionality and MS-Word integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security.
- The MasterControl Submissions Locker™ provides a secure, Web-based location where access to submission documents can be easily controlled. This solution is designed for companies that, in lieu of using their own eCTD software, wish to send their submission documents to a third-party to construct the eCTD document. After authentication, MasterControl's eCTD system allows publishing tool of choice to access the Submissions Locker as a standard file share. All access rights are controlled exclusively by MasterControl login parameters.
- MasterControl Submissions Gateway™ provides a simple mechanism for creating copies of approved submission documents in the desired folder structure to share with a submission publishing group or contractor. (This solution is recommended only when a company is not using eCTD software but instead contracting out this function.)
Top 12 Ways to Ensure Success with eCTD Software
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:
- Include Tables of Contents in all PDF documents.
- Be sure all PDF hyperlinks and bookmarks are correct.
- All XML documents must use standard components.
- All documents should conform to eCTD granularity.
- Verify that all MD5 check sums are correct.
- Do not use node extensions in the eCTD software.
- Make sure all sequence numbers are four digits.
- Make sure all application numbers are six digits.
- Include Module 1 in all eCTD submissions.
- Be sure to reference all files in the XML backbone(s).
- Use elements and leaf titles correctly.
- SPL must be in an 'SPL' eCTD software folder.
For More Information about eCTD Systems
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.
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To learn more about MasterControl's software systems, please contact a MasterControl representative.
