Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPS community,

We are a small company that mostly acts as an importer for its parental company overseas. Recently, we are having a conversation about organizing our Letter to File printed versions more systematically, so that they are better traceable and readily looked up. However, I am having a hard time keeping the printed copies - there are about 2-3 LTFs issued per week, and they contain a lot of information - thus requiring us to use many printed papers (trees). I am wondering if we can just maintain the electronic version of copies, without printing out hard copies?

Thank you

Dear Anonymous,

This is an interesting question and I look forward to additional input. First of all, what is considered the "official" or "original" source? Does your organization have a definition of what would be considered the original?  Is the paper copy a verified version of the  electronic document (PDF)?  Or, is it a print out of the PDF which is the original or official source document,  so, then I would propose you don't need to print out hard copies as a matter or routine and to save trees.  If a hard copy is the official or original source document, then I would propose you need to keep the hard copy as it is the original. I am assuming that the PDF if the original as with DocuSign or signature of a PDF is pretty standard practice and can be traced for signature and location if needed.  

On another note, and just curious, what are the Letter to Files for? 2-3 issued a week? Probably not germane to your question. 

Not sure this is helpful but I wanted to try to get discussion going! 

Can't wait to see what other input is provided! Great and different question.

Dar

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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 22-Mar-2022 15:11
From: Anonymous Member
Subject: Letter to File - hard copies necessary?

This message was posted by a user wishing to remain anonymous

Hello RAPS community,

We are a small company that mostly acts as an importer for its parental company overseas. Recently, we are having a conversation about organizing our Letter to File printed versions more systematically, so that they are better traceable and readily looked up. However, I am having a hard time keeping the printed copies - there are about 2-3 LTFs issued per week, and they contain a lot of information - thus requiring us to use many printed papers (trees). I am wondering if we can just maintain the electronic version of copies, without printing out hard copies?

Thank you

If you want to avoid the specter of Part 11's electronic record requirements, then FDA requires you to a) keep a paper version of any record required by agency regulations; and b) be able to make the case that the paper versions are the versions on which you rely to meet your regulatory obligations.  I explain further below.

For the medical device sector, and presuming that your Letters to File are those prepared in relation to 21 CFR 807.81(a)(3) regarding changes to an existing device legally marketed under section 510(k) of the FD&C Act ("the Act"), or prepared in relation to 21 CFR 814.39 (e.g., paragraphs b, e, etc.) regarding changes to an existing device legally marketed under section 515 the Act (PMA), then first remember that the Letters to File constitute mandatory records to be kept pursuant to the regulations I mentioned above in combination with, as applicable, 21 CFR 820.30(i) (design changes).

Next, when pondering the keeping of the aforesaid required records in electronic format instead of paper format, remember that 21 CFR 11.1(a) & (b) (as currently enforced with certain discretion by the FDA) require that electronic versions of required records must comply with applicable provisions of Part 11 if 1) those electronic records are kept instead of paper versions; or 2) they are kept in addition to paper yet where the electronic version, not the paper version, is actually the version relied upon to meet your regulatory obligations.

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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 22-Mar-2022 15:11
From: Anonymous Member
Subject: Letter to File - hard copies necessary?

This message was posted by a user wishing to remain anonymous

Hello RAPS community,

We are a small company that mostly acts as an importer for its parental company overseas. Recently, we are having a conversation about organizing our Letter to File printed versions more systematically, so that they are better traceable and readily looked up. However, I am having a hard time keeping the printed copies - there are about 2-3 LTFs issued per week, and they contain a lot of information - thus requiring us to use many printed papers (trees). I am wondering if we can just maintain the electronic version of copies, without printing out hard copies?

Thank you