Original written signatures vs. Copies/scans/faxes/electronic documents

[MIREGMGR]

He stated that if you destroy the original, you must verify the scan to the original document first to confirm that the scan contains all of the original (pgs. and text) and is ledgible. This must be a documented activity.

Has he indicated on what 21CFR section, or FDA guidance, or FDA statement or action he bases his stance?

Expert opinions are great, but I need something textual to point to.

 

[MIREGMGR]

Anyone here an expert on the 33 pages of comments-and-responses in the Federal Register 20MAR1997 publication of the Final Rule?

 

[kathykru]

Subpart J--Records and Reports

Sec. 211.180 General requirements.


(d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available

He points to the above, stating the regs reguire "true copies" or other "accurate reproductions of the original records". He stated that it is the FDA expectation that if you discard the original (which would be your evidence that the copy is accurate and complete) there must be some other evidence that the firm has an accurate reproduction of the original. Thus, he recommends (certainly NOT a reg, but his recommendation on how to provide such evidence) - the review of the original against the copy with the certification that it is accurate and complete.

I personnally have had instances where a scan copy cut off words on the edges, and even missed a page during the scan.

 

[MIREGMGR]

He points to the above, stating the regs reguire "true copies" or other "accurate reproductions of the original records". He stated that it is the FDA expectation that if you discard the original (which would be your evidence that the copy is accurate and complete) there must be some other evidence that the firm has an accurate reproduction of the original. Thus, he recommends (certainly NOT a reg, but his recommendation on how to provide such evidence) - the review of the original against the copy with the certification that it is accurate and complete.

In the scenario that you mention, do the records carry a signature?

His analysis makes sense of course in regard to archiving. I believe the legal substitutability of a reproduction of a physical signature in place of the original physical signature is a separate question, though.

Thanks for your response.

 

[BradM]

In the scenario that you mention, do the records carry a signature?

His analysis makes sense of course in regard to archiving. I believe the legal substitutability of a reproduction of a physical signature in place of the original physical signature is a separate question, though.

Thanks for your response.

The scan of the document has the original signature. The scanned document then becomes the best document available, and is used for the purposes at hand.

I did ask around, and the scanned images are used, as opposed to storing all the original data. I just didn't get around to getting the CFR citation yet.

 

[Jim Wynne]

The scan of the document has the original signature.

It can't be a scanned copy and original at the same time, except perhaps at the quantum level.

 

[BradM]

It can't be a scanned copy and original at the same time, except perhaps at the quantum level.

Hello, Jim. Hope things have been going OK for you.

 

[bonnieblue]

Based on these guidelines by the FDA, medical device companies should not shred their originals.

http://web.archive.org/web/20080223195921/http://www.fda.gov/cdrh/elecsub.html

Hi Jan,

Do you happen to have the name of the article? this link no longer works and i am very interested in what it had to say. Thanks!

 

[MIREGMGR]

Since this earlier discussion, we have been told verbally by FDA that their current stance is exactly what KathyKru said above in her 15th May 2009, 10:08 AM post (post #10), i.e. a scan or other image of a document carrying an original physical signature is acceptable only if a separate process at the time of scanning or imaging has verified that the scan or image is a true copy, and that separate process has been attested with the signature of the responsible individual.

 

[Jim Wynne]

Since this earlier discussion, we have been told verbally by FDA that their current stance is exactly what KathyKru said above in her 15th May 2009, 10:08 AM post, i.e. a scan or other image of a document carrying an original physical signature is acceptable only if a separate process at the time of scanning or imaging has verified that the scan or image is a true copy, and that separate process has been attested with the signature of the responsible individual.

This reminds me of the experience of someone I know who, while serving in the military, had to review certain documents and initial them as evidence of review. One day a document he had reviewed came back to him with a note attached: "This document was forwarded in error and should not have been reviewed. Please erase your initials and initial your erasure."