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Tamar June

FDA Compliance

FDA Warns WebTrader Users: Remove Your Files or Lose Them

On Feb. 1, 2013, WebTrader inboxes with more than 20 documents will be cleaned. No retrievals.

Published: Monday, January 21, 2013 - 18:05

A Jan. 11, 2013, email sent by Michael Fauntleroy, program manager for the Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG), the agencywide solution for accepting electronic regulatory submissions, warns those using the WebTrader for electronic submissions to delete their inboxes, or risk losing all documents contained within them in the future. WebTrader is supposed to be a low-volume submission tool; however, some companies have apparently been using the system as a file server or archival system.

The FDA states that the misuse of the system has resulted in significantly lower performance for all other account holders. It suggests removing the submission records and storing them either locally or on a companywide network. The email also listed the number of “offending” accounts:
• 1 account has more than 3,000 documents
• 9 accounts have more than 2,000 documents
• 34 accounts have more than 1,000 documents
• 96 accounts have more than 500 documents
• 763 accounts have more than 100 documents
• 2,833 accounts have more than 20 documents

(Each submission transmission has three to four documents associated with it, so 20 documents in an inbox translates to five or six submissions.)

According to the FDA: “ESG’s WebTrader functionality is provided to the industry by FDA as a low-cost alternative to send submissions to FDA. The WebTrader Inbox provides the users a view of submissions sent to FDA, and receipts and acknowledgements received from FDA. This inbox should not be used as a storage place for your receipts and acknowledgements. Once you receive receipts and acknowledgements for your submissions, you should:
• Download receipts and acknowledgements and save them to your local machine.
• Delete records from your WebTrader inbox

Following these steps will ensure faster display of the Inbox for you and other ESG users, and increase overall performance of the system.”

The following policy statement was included in the email: “The account owners that have more than 2,000 documents in their WebTrader Inboxes will be receiving an email with a zip file of their messages. We will delete these documents from your WebTrader Inbox at the FDA immediately. This policy is being re-implemented on a permanent basis.”

In the closing paragraph of the email, in red ink, the FDA sternly warns: “On Feb. 1, 2013, we will start deleting documents in WebTrader account inboxes without notice. Any WebTrader inbox with more than 20 documents in it will be cleaned starting Feb. 1, 2013. Once the Inbox is cleared of documents (receipts and acknowledgements), they cannot be retrieved, so WE STRONGLY ADVISE YOU TO DOWNLOAD RECEIPTS AND ACKNOWLEDGEMENTS FROM YOUR INBOX after each transmission.”

Clearly, those who have hundreds or thousands of documents should probably consider upgrading to another type of eMDR submission system.

Article by Tamar June. First published in the Jan. 17, 2013, AssurX blog.

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About The Author

Tamar June’s picture

Tamar June

Tamar June is vice president of strategic marketing and product manager for AssurX Inc., a provider of enterprise quality and compliance systems to a variety of industries including medical device, pharmaceutical, biotech, electronics, aerospace and contact manufacturing. She has spent the past 17 years in both manufacturing and information technology.