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

M

MIREGMGR

#1
A search reveals that this topic has been discussed here at considerable length...but without much actual evidence one way or the other.

Does anyone know of a written FDA stance or comment on original signatures vs. copies/scans/faxes, anywhere...?

Maybe in a 483, or some other obscure communication?

Our management wants to begin scanning must-retain signed paper records, then shredding the originals. The cost savings for storage space and office-staff labor would be significant.

The scanning would not be a Part 11 compliant process, since there is no live linkage at scan-time from the original document creator/signer to the identify assigned to the resulting scan-file.

:notme:
 
M

MIREGMGR

#3
Are you referring to a physically written signature on a piece of paper?
Yes...as contrasted to an image or pixelization of that physical signature, and then the printing of that image onto a new piece of paper.

By the way, the title of the OP was edited to add "electronic documents"...which changes the direction to the thread in a way I had not intended.

21CFR Part 11 is quite clear regarding the requirements and handling of documents that never go through a paper stage, and signatures that are originally created and affixed in electronic form.

The intended question pertains to originally-paper documents that constitute FDA-required records and are originally signed in physical form, and whether the FDA has made any written statement as to the acceptability of a copy, scan or fax of such a physically-signed paper document as equivalent for regulatory purposes to that original physically-signed paper document.

I'm aware of several narrowly limited instances of such statements, i.e. 510(k) filings and mammography reports must have original physical signatures, and probably one or two other narrow categories. I'm looking for a general statement.
 

Marc

Captain Nice
Staff member
Admin
#4
By the way, the title of the OP was edited to add "electronic documents"...which changes the direction to the thread in a way I had not intended.
I did that purposefully to include the electronic signature aspect in case that was / is relevant.

Tell me if I did 'wrong'. I can easily change the thread title.
 

BradM

Staff member
Admin
#6
A search reveals that this topic has been discussed here at considerable length...but without much actual evidence one way or the other.

Does anyone know of a written FDA stance or comment on original signatures vs. copies/scans/faxes, anywhere...?

Maybe in a 483, or some other obscure communication?

Our management wants to begin scanning must-retain signed paper records, then shredding the originals. The cost savings for storage space and office-staff labor would be significant.

The scanning would not be a Part 11 compliant process, since there is no live linkage at scan-time from the original document creator/signer to the identify assigned to the resulting scan-file.

:notme:
An interesting question. I'm thinking there is something in a CFR, but I am unsure.

To me, this plays with the other thread on signing job descriptions. In regulated industries we have been so ingrained with the notion of signing everything, signature is everything, etc. I'll do some checking around.
 
M

MIREGMGR

#7
Based on these guidelines by the FDA, medical device companies should not shred their originals.
I referred to the premarket-submission guidelines in my post above as "510(k) filings"...but these rules' signature requirements are specialized. I don't think they can reasonably be said to be applicable to all medical-device-maker records.

Please explain, though, how you're deriving general guidance on shredding of originals from this document. I can't find any such inference.

There is an explicit requirement for physical signatures in the mammography reporting guidance as well.
 

BradM

Staff member
Admin
#8
Yes...as contrasted to an image or pixelization of that physical signature, and then the printing of that image onto a new piece of paper.

By the way, the title of the OP was edited to add "electronic documents"...which changes the direction to the thread in a way I had not intended.

21CFR Part 11 is quite clear regarding the requirements and handling of documents that never go through a paper stage, and signatures that are originally created and affixed in electronic form.

The intended question pertains to originally-paper documents that constitute FDA-required records and are originally signed in physical form, and whether the FDA has made any written statement as to the acceptability of a copy, scan or fax of such a physically-signed paper document as equivalent for regulatory purposes to that original physically-signed paper document.

I'm aware of several narrowly limited instances of such statements, i.e. 510(k) filings and mammography reports must have original physical signatures, and probably one or two other narrow categories. I'm looking for a general statement.
OK, now I'm getting confused.:D Requiring original signatures on documentation, and the method of archiving/electronically storing that documentation may be two different things. For example, you may have a policy of storing original documentation until, submission, ( or two years, or whatever), then scanning the document as best document available.

Are you wondering about original signature, archiving, or both?
 
M

MIREGMGR

#9
Are you wondering about original signature, archiving, or both?
The records in question are created on paper, and receive an original physical signature. The internal proposal is then to scan them, store the scans electronically, and shred the originals. A record that was to be subsequently referenced or otherwise utilized would be printed onto paper for that utilization process...thus simulating the original document, but with a reproduced signature instead of a physical original. As noted above, this would take place in a non-Part-11-compliant context.

Because it's relevant in focusing the discussion, the types of documents in question are production records for validated processes utilized to manufacture defined-sterile-packaged-lifetime batches of Class II single-use disposable devices. These records constitute part of our DHR for these products.
 
K

kathykru

#10
Hello,

I work for a drug company and have an ex-FDA Consultant on site doing a PAI Inspection, and this exact question was asked.

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.

Based on his recommendation, we are not going to destroy originals.

Hope this helps!
 
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