How to Avoid Validation Errors on Scanned FDA Forms

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Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms. The accepted practice is to include two copies of the form in your submission:

  • An unsigned copy of the fillable form, to be used by FDA to automatically process your submission; and
  • A signed, scanned copy of the form to provide a signature.

Although this practice is acceptable to FDA, it can result in several validation errors. Here’s how to avoid these errors.

How to Avoid Validation Errors on Scanned FDA Forms

Error 5057

When submitting a signed, scanned copy of the form, you will receive validation error 5057, Document contains no text. The error message elaborates that, “You have submitted a document that is a scanned image only and is not text searchable.”

To resolve this error, perform Optical Character Recognition (OCR) on the document. Through this process, an invisible layer of searchable text is added to the PDF to correspond with the text in the scanned image.

Errors 5025 and 5032

Depending on how you’ve named your files, you may receive one or both of these errors:

  • Error 5025, US application form is not a fillable form; and
  • Error 5032, Multiple application forms present for the same application.

If your signed, scanned copy of the form includes the form number in the file name (e.g., signed-1571.pdf), you will receive Error 5025. If both your fillable copy of the form and your signed, scanned copy of the form include the form number in the file name, you will receive Error 5032.

To avoid both errors, CDER’s Electronic Submissions Team recommends the following file naming convention:

  • Name the fillable form, “form-[form number].pdf” (e.g., form-1571.pdf); and
  • Name the signed, scanned copy of the form, “signed-form.pdf”.

Error 5029

If you’ve followed the advice above, you should expect to receive Error 5029, Misnamed form. This occurs when a file is submitted in module 1.1 without the form name in the file name. Thus, this error is triggered by the “signed-form.pdf” file.

If you are not using electronic signatures, this error is unavoidable. However, since we know this practice is acceptable to FDA, and we know that Low severity errors will not automatically result in a technical rejection of your submission, our advice is that this error can be ignored in this situation.

The only way to resolve this error would be to use an electronic signature on the fillable FDA form.

Conclusions

Using electronic signatures to sign your Form FDA 356h or 1571 is the best option. However, if you’re not able to do this, the steps outlined above will help you limit the number of validation errors you receive from as many as three errors down to one Low severity error, which can be safely ignored.

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Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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