eSubmitter Verifier

Issue:  An issue has been identified in the FDA mandated eSubmitter V3 software.  It primarily affects large submissions like PMTAs and TMPFs and is likely due to the rapid deployment of tools required by FDA to meet the court mandated deadline. 

Details:  This issue causes eSubmitter to fail to include random submission files when creating transmittal zip files.  This results in a difference between what the Sponsor sent and what the FDA receives.  As a result, it is possible that PMTA and TPMF applications may be incomplete which could jeopardize the application.

Solution:  Delphinus is offering a free open-source software to help identify submissions that have experienced this issue

Complete the form to Download Verifier

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Delphinus Transmittal Verifier

Instructions:

  1. To install read the README.txt in the ZIP download.
  2. Click “Select Zip File” and pick the first zip file that eSubmitter created for the submission.
  3. The panel on the right will display any missing files and a list of all files included in the submission.
  4. Click “Copy to Clipboard.”

Output:

  1. Dropped Files – Added to eSubmitter but excluded from the Submission Report
  2. Missing Files – Reported to FDA as part of the submission but not included in the zip file.
  3. Extra Files – Included in the submission but not in the Submission Report
  4. File List – All files included in the Transmittal files

General Use:

Delphinus recommends using this utility after creating any eSubmitter transmittal file.  If a file is missing you should try to remove and re-add the specific file in eSubmitter until it is in the File list and not in the Missing Files.

PMTA / TPMF Rescue:
Using this software you can identify any files that have not been submitted to FDA.  Delphinus recommends the Sponsor create an amendment that includes:

  1. Cover Letter – Indicating that documents failed to upload in the original submission due to an issue with eSubmitter.
  2. Document Tracking – A list of all content files and why they were included.
  3. Missing Documents – All missing documents using the same folder structure and file names of the original submission.  Only include the missing files, not the full submission.
  4. Table of Contents – A table of contents for each module and the rescue submission as a whole.

eSubmitter Verifier Details

The eSub Verifier is a utility released as open-source freeware.  It is written using C# with a .NET framework and is compatible with Windows.  In addition, Delphinus is providing a Windows Power-shell script that will allow your IT team to assess the source code and compile the software locally to ensure the security and integrity of your tobacco applications.  The source code is also available at: https://github.com/delphinusconsulting/eSub-Verifier.  It is provided under the GPLv3 license and has no warranty either explicit or implicit.  Use at your own risk.

The software functions by examining the XML configuration files present in the Transmittal package created by eSubmitter, for large submission it reads the first zip file created.  It then checks the data for consistency and cross checks against all the files actually included in the submission zip files.  Finally, the software provides a list of any errors identified and a comprehensive list of submission files that can be compared to the original source to ensure all files are present as expected.

 

If you have any questions please contact Delphinus with the form below.

For more information about who we are and what we can do for your submission, please contact us!