What Type of Documents Need to be Certified When eFiling?

[Janet Wright]

Hello!

We are planning to archive our paper TMF in electronic format and need some guidance on which types of documents should be certified copies. Would we only need to certify those documents that have a wet signature? Or that were received in paper format originally?

For example, if we received an electronic file and then printed for the TMF, would we need to scan that copy back in and certify it? Could we use the original electronic file although it has been maintained in a non 21 CFR Part 11 system for the past few years? Or can that type of document be QC’d on a risk-based approach?

Thank you so much for your guidance on this matter!

Many warm regards,
Janet

[Karen Roy]

Hi Janet
The regulations state that if you have paper originated documents that you destroy, the copies should be certified. If you have the files electronically, you could use these and not scan and certify, but I would personally assess the effort of just scanning all the documents from paper (certified process) versus scanning some and finding some electronic and filing the electronic ones in between the scanned paper documents!
In addition, you need to be sure that the electronic documents have not been changed over the years.
Karen

[Janet Wright]

Thank you very much for the prompt reply, Karen!

A follow-up question… If you are scanning an entire TMF: is there any guidance on whether you should mark as certified each file individually, or if you can have a blanket certification that would cover the entire process or batches? For example, if your transfer plan describes the scanning and the initial and second QCs, would it be acceptable to have a single sign off at the end?

Thank you again!

[Qiutao Yu]

EMA Guideline: Guideline on the content, management and archiving of TMF_6Dec2018 section 5 has provided clear instructions on this.

For the follow up question, my personal thinking is that it could be acceptable as long as the process is “validated”. For example, set a series of Criteria for risk-based QC:

1. Documents that are essential per ICH GCP 8 should be 100% QCed
2. A certain percentage of other non-essential documents to be verified. If errors, then should expand the scope/volume of documents to be checked.

• This reply was modified 6 months, 1 week ago by Qiutao Yu.

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