Hi,

I have a multisite/multinational business and regarding approval of design documents, we accept faxes of hand signatures from colleagues in India and Europe and the original signatures are then sent via regular mail. I've questioned the need for all of this effort (mail orinal signatures etc...). We do retain all documents and signatures as records, but my research hasn't found anything that states that having faxed handsignatures in you DHF is not ok. 21 CFR Part 11 clearly states that fax signatures is out of scope. I think our QS just needs to be revised to state that use of faxed handwritten signatures as evidence of document approval is acceptable.

Any thoughts on the subject?

Thanks in advance...........

If there is no requirement then I couldn't care one way or the other as long as you can show positive and effective control.


:topic:What is this BSI cert in your profile?

If there is no requirement then I couldn't care one way or the other as long as you can show positive and effective control.


:topic:What is this BSI cert in your profile?

Mmmm - that's what I wanted to know, too...........;)

Thanks Randy.

FYI, The BSI Cert in my profile refers to BSI Lead Auditor Certification.

On your response, any thought on what would show adequate controls. If you're talking about review and approval processes, I can see where you're coming from. But if you're talking about adequate controls of faxed front pages that have a handwritten signature, I'm not sure what you mean.

Peter:thanx:

Hi,

I have a multisite/multinational business and regarding approval of design documents, we accept faxes of hand signatures from colleagues in India and Europe and the original signatures are then sent via regular mail. I've questioned the need for all of this effort (mail orinal signatures etc...). We do retain all documents and signatures as records, but my research hasn't found anything that states that having faxed handsignatures in you DHF is not ok. 21 CFR Part 11 clearly states that fax signatures is out of scope. I think our QS just needs to be revised to state that use of faxed handwritten signatures as evidence of document approval is acceptable.

Any thoughts on the subject?

Thanks in advance...........

To my way of thinking, a faxed copy of an approval is little different to a photocopied approval. Sure it came over the 'wire' rather than having someone send it in the mail etc. then throw it on a photocopier. These days, most fax machines operate on the same principle as a copier, anyway!

Can I ask, for our readers, what's the background to this question?

Background of question:

My group is part of a larger organization and we have to operate accoring to their existing QS. As I said in my original message, we operate accross US, Europe and AP, in developing product and may of our project documents (such as project plans, requirements documents, test plans) receive review and approval from people at remote sites. We don't yet have a system for managing electonic signature approval of documents to 12 CFR Part 11, so we fax handwritten signatures of the front page of documents. The existing process is to have original signatures sent via regular mail to the author after the faxed signature is sent. This process adds effort and I'm questioning whether it is even necessary. If we can treat a signed fax as if it were an original and then get rid of the need to manage having the originals sent around the planet, I'd like to do that. I can't find anything that says I can't do that, so I thought I'd run the issue by you-all at Elmar Cove.

Thanks Randy.

FYI, The BSI Cert in my profile refers to BSI Lead Auditor Certification.


Peter:thanx:


Peter who? Send me an email or PM

Sorry for the multiple typos:

My group is part of a larger organization and we have to operate according to their existing QS. As I said in my original message, we operate accross US, Europe and AP, in developing product and many of our project documents (such as project plans, requirements documents, test plans) receive review and approval from people at remote sites. We don't yet have a system for managing electonic signature approval of documents to 21 CFR Part 11, so we fax handwritten signatures of the front page of documents. The existing process is to have original signatures sent via regular mail to the author after the faxed signature is sent. This process adds effort and I'm questioning whether it is even necessary. If we can treat a signed fax as if it were an original and then get rid of the need to manage having the originals sent around the planet, I'd like to do that. I can't find anything that says I can't do that, so I thought I'd run the issue by you-all at Elmar Cove.

If we can treat a signed fax as if it were an original and then get rid of the need to manage having the originals sent around the planet, I'd like to do that. I can't find anything that says I can't do that, so I thought I'd run the issue by you-all at Elmar Cove.
I'm sure my POV is not the majority view, but I always have a nagging doubt (having seen it abused in the past) of photocopied and faxed signatures. A reproduction of a signature is just that, a reproduction, it can be faked - a signature copied from another document and pasted onto the "new" record is indistinguishable once photocopied, and thus provides a source of risk.

In a past life we accepted a signed fax only if countersigned by the local QA representative, or an independent third party. The fax had to be reconciled with the original, signed in blue ink, within 14 days of the nominal date or a CAPA was initiated to investigate the signature provenance.

Paranoid? Maybe.... but we considered the risk too significant to ignore.

Like I said I doubt that this is the majority view, just my 2 cents :2cents:

Hi,

I have a multisite/multinational business and regarding approval of design documents, we accept faxes of hand signatures from colleagues in India and Europe and the original signatures are then sent via regular mail. I've questioned the need for all of this effort (mail orinal signatures etc...). We do retain all documents and signatures as records, but my research hasn't found anything that states that having faxed handsignatures in you DHF is not ok. 21 CFR Part 11 clearly states that fax signatures is out of scope. I think our QS just needs to be revised to state that use of faxed handwritten signatures as evidence of document approval is acceptable.

Any thoughts on the subject?

Thanks in advance...........

The similar practise was used in one of my previous Pharmaceutical company.

The faxed signature copy had to be verified by a "responsible" person with a justification provided for fax copy. This would be filed along with the main document as an attachment. The original copy, that was received at a later date was also filed as an additional attachment. All these steps were clearly identified in the procedures.

This was reviewed by FDA in their audits and was found acceptable.

I have a multisite/multinational business and regarding approval of design documents

Obtaining sigantures from across multi-national is difficult at the best of times and using a fax copy solely IMHO is acceptable for certain documents, however for design documents I would be be wary. These documents could be used in court of law should you need to demonstrate safety, duty of care etc etc. I am not sure sure how legally binding a reproduction of someones signature is and furthermore how you would prove that the date along side the signature is correct.

we accept faxes of hand signatures from colleagues in India and Europe and the original signatures are then sent via regular mail.

I would talk to legal before I revoked this requirement

I've questioned the need for all of this effort (mail orinal signatures etc...). We do retain all documents and signatures as records

Should the worst occur what would you rather have? orginals or copies?

I think our QS just needs to be revised to state that use of faxed handwritten signatures as evidence of document approval is acceptable.

As mentioned before I would talk to legal first, but additionally you need to consider where this might go, could someone on the first floor fax their approval to the third floor... if it is acceptable distance is not a consideration!

and what happens to all the originals how are they controlled, who is responsible.... I guess think about what is more work, posting the original or having different sites have to control them (procedurally).

:2cents:

In a past life we accepted a signed fax only if countersigned by the local QA representative, or an independent third party. The fax had to be reconciled with the original, signed in blue ink, within 14 days of the nominal date or a CAPA was initiated to investigate the signature provenance.

Paranoid? Maybe.... but we considered the risk too significant to ignore.

Like I said I doubt that this is the majority view, just my 2 cents :2cents:

Whoa! I would look at control at that level as a containment action until the paranoia could be eliminated from the fabric of the organisation. What happened if someone used black ink, or even red?!!! A CAPA in this instance IMO is such a wast of resource...."Root Cause - insufficient blue pens on stationary order!!!!!"

Back to the OP - I am unfamiliar with the standards you are referring to or the real significance of the documents in question, but I do not see the trouble in using these documents, as long as the system is unlikely to be abused. Look at the risks, Can the system be abused (in this case yes it maybe could), what is the likelihood anyone will bother to abuse it (????) and what will the result be if someone did abuse it (????). If originals are kept in their original location and are available what is the problem? Like Randy said originally, as long as you can demonstrate sufficient control.

Perhaps the alternative approach will be to try and eliminate the fear associated with signing things off. This will then reduce or even eliminate the likelihood of abuse. Is there a culture of Blame and fear in your org? How well do these remote locations work together? Does everyone understand why they sign things and the implications if problems arise as a result?

Of course these are much more deep rooted culture issues, you may just want to keep mailing them, but it's food for thought!

Whoa! I would look at control at that level as a containment action until the paranoia could be eliminated from the fabric of the organisation. What happened if someone used black ink, or even red?!!! A CAPA in this instance IMO is such a wast of resource...."Root Cause - insufficient blue pens on stationary order!!!!!"


Not only that, but unless you have a forensic handwriting analyst on staff, you have no real way of knowing whether original signatures are genuine or not. I know next to nothing about the minutiae of FDA and medical requirements in general, but if there's no specific proscription against accepting faxed documents, there probably isn't a good reason not to accept them. If the distrust of the source is such that there's a reasonable perception of risk in accepting a faxed signature, that problem should be addressed.

I'm sure my POV is not the majority view, but I always have a nagging doubt (having seen it abused in the past) of photocopied and faxed signatures. A reproduction of a signature is just that, a reproduction, it can be faked - a signature copied from another document and pasted onto the "new" record is indistinguishable once photocopied, and thus provides a source of risk.

In a past life we accepted a signed fax only if countersigned by the local QA representative, or an independent third party. The fax had to be reconciled with the original, signed in blue ink, within 14 days of the nominal date or a CAPA was initiated to investigate the signature provenance.

Paranoid? Maybe.... but we considered the risk too significant to ignore.

Like I said I doubt that this is the majority view, just my 2 cents :2cents:

I have to go with Jimmy on this one. We'll both be making tinfoil hats for sale!:lol:

I bit of explanation here. My experience in an FDA-regulated industry (and FAA to a lesser extent) is one that has developed an obsession for original documentation, everything is reviewed and signed, no empty spaces, etc. Also, photocopies (or faxes) are not made of any document unless it is complete with all signatures in original ink. It plays to the signatures (whether original or electronic) being legally binding.

Now, I cannot point to a spot in a CFR or other document that shows the Thou Shalt. This may be practices that are outdated, and not part of any requirement anymore. However, when one has a system that satisfies the FDA, one is reluctant to make changes.:D If anyone can show me a relaxed interpretation from the FDA on this stuff, I'll owe them big!

Photocopy and faxed copies are accepted when it is the best document available, and stamped as such.

The only thing I can add is that a few years back ~ 5, we had an FDA audit where the inspector would not accept a copied/faxed signature thay all had to be original. To be honest with you I don't remember what became of it (I have since moved on to another employer).

Not only that, but unless you have a forensic handwriting analyst on staff, you have no real way of knowing whether original signatures are genuine or not.

To this I would ask why there is a requirement to sign at all!!

I know next to nothing about the minutiae of FDA and medical requirements in general, but if there's no specific proscription against accepting faxed documents, there probably isn't a good reason not to accept them. If the distrust of the source is such that there's a reasonable perception of risk in accepting a faxed signature, that problem should be addressed.

Accepting the fact that the original signed copy must be kept... although I am unsure whether you advocate this... if the fax is good why keep an original.. the control of a complete file is easier if it is in one place, if you have parts of the file in another office let alone the other side of the world it can be difficult to compile the complete set esp. after 6 - 12 months lapsed.

I do not think its a case of distrust, I think its more a case of control, I believe that if you needed to produce the document for an inspector or worse case for a jury the original would carry a lot more weight and reverence. Ensuring that different sites around the world keep sufficient control with ever changing staff is a lot harder and more effort that posting the original... and if worked out probably more cost effective too.

The only thing I can add is that a few years back ~ 5, we had an FDA audit where the inspector would not accept a copied/faxed signature thay all had to be original. To be honest with you I don't remember what became of it (I have since moved on to another employer).

And I think Aaron has hit the nail on the head with the fact that this isn't a matter of whether the FDA or similar requirements allow/prevent use of faxed signatures, it's more a case of a personal (and rather unpleasant bias) on the part of the specific auditor.............

Hi,

Thanks for all of the feedback on the question of faxed handwritten signatures.

On the topic of getting legal involved, I use legal for contract reviews and such, but they're so conservative with interpretations that I don't ask for their involvement on these types of issues.

What I've concluded after talking with the FDA, our Notified Body, tons of colleagues, review all of the regulations and guidances is that faxing of handwritten signature is ok, but using scanned pdfs within e-mails is better. In order to demonstrate control using pdf in e-mails ensures that the sender contacts the author directly and they can compare the printed scanned page to the e-mail copy. To be totally 'secure' the use of a fax is fine with a preference to have the machine access limitted to a small number of people. I realize that some of you may be in a position where you don't feel confortable doing this. In our case, it is much more efficient and less error prone and just the right thing to do.:thanx: