How to Link Electronic Records (510k Documents) to Handwritten Signature

[Jennifer27]

Hi All!!

I have a problem in which our consultant has limited experience, I would highly appreciate the help of the regulatory experts on Elsmar.

Our company is in USA, we have a regulatory consultant in country A and a sister branch of our company, where all the regulatory 510k documents have been prepared and the testing of our device was performed, in country B.

We have prepared all our documents required for 510k submission in pdf. We used to send these to our consultant through email and he reviewed them and sent them through email.

With each document we have a revision history. I was wondering if our sister branch in country B should take print outs of all complete documents, to be submitted to the FDA for the 510k, sign and send to us (company in USA) OR they can only take print outs of revision history (single page, giving details of reviewer etc and uniquely linking to an electronic record) sign it also send it to the consultant, he also signs it and sends to us in USA.

I would highly appreciate your input. Please help

 

[yodon]

Well, I must say, I kind of got lost in all that and I'm not sure I completely understand what you're trying to accomplish.

It sounds like you're saying you are suggesting that printing a hardcopy of the pages with signature blocks & revision history and then "wet ink" signing that would link it to an electronic record. I don't see that being defensible.

Document Control (whichever country) needs to manage the approved documents and their distribution. If you want to have an electronic record that requires signature, I don't see how you can do that without an electronic signature.

We frequently work with off-site clients that sign a copy of the cover page then fax it to us, we sign the original, & attach both to the hardcopy. Clearly that process has potential for misuse but it's been acceptable up to this point. The signatures are associated with the hardcopy (which is kept and, as necessary, copied / distributed; e.g., to FDA, by doc control).

Not sure if that helps. Maybe re-state what you want to accomplish or where you feel uncomfortable.

 

[Jennifer27]

It sounds like you're saying you are suggesting that printing a hard copy of the pages with signature blocks & revision history and then "wet ink" signing that would link it to an electronic record. I don't see that being defensible.

Yes we will be doing the same "printing a hard copy of the pages with signature blocks & revision history and then "wet ink" signing" and in order to link to an electronic record we will provide electronic record unique details ( like the name of the record, create/modify time and date, its size (in Kb, as it would appear on the computer), format (pdf)). After this time to time manual audit trails will be conducted to prevent any unauthentic changes to the records. The audit trails will be signed and maintained in separate and parallel paper records. The audit trails will be conducted in our sister branch in country B. Now the audit trail records, signed pages will be sent on the mailing address of our main branch in USA (here I guess we can use fax?) and the complete 510k submission documents will be emailed to us in USA by our sister branch in country B, we in USA will take print outs ( or you would suggest that we should ask our sister branch in country B to take print outs of the complete 510k submission documents and send them to us through fax?). Finally we submit all documents to FDA with the signed pages and audit trails. Will this be acceptable? OR would you suggest to adopt any alternate method?

Can you please suggest any way to include the signature of the consultant who in country A? OR We should keep the documents just between us in USA and our sister branch in country B and skip the signature of consultant because that might make our compliance complex, as we will then have to be concerned about our interaction with the consultant (as we sent him all the documents through email and he sent us all the reviews through email).


Thanks so much for your time and prompt response. I look forward to your input.

 

[simonyeeklang]

It sounds like you're saying you are suggesting that printing a hard copy of the pages with signature blocks & revision history and then "wet ink" signing that would link it to an electronic record. I don't see that being defensible.

Yes we will be doing the same "printing a hard copy of the pages with signature blocks & revision history and then "wet ink" signing" and in order to link to an electronic record we will provide electronic record unique details ( like the name of the record, create/modify time and date, its size (in Kb, as it would appear on the computer), format (pdf)). After this time to time manual audit trails will be conducted to prevent any unauthentic changes to the records. The audit trails will be signed and maintained in separate and parallel paper records. The audit trails will be conducted in our sister branch in country B. Now the audit trail records, signed pages will be sent on the mailing address of our main branch in USA (here I guess we can use fax?) and the complete 510k submission documents will be emailed to us in USA by our sister branch in country B, we in USA will take print outs ( or you would suggest that we should ask our sister branch in country B to take print outs of the complete 510k submission documents and send them to us through fax?). Finally we submit all documents to FDA with the signed pages and audit trails. Will this be acceptable? OR would you suggest to adopt any alternate method?

Can you please suggest any way to include the signature of the consultant who in country A? OR We should keep the documents just between us in USA and our sister branch in country B and skip the signature of consultant because that might make our compliance complex, as we will then have to be concerned about our interaction with the consultant (as we sent him all the documents through email and he sent us all the reviews through email).


Thanks so much for your time and prompt response. I look forward to your input.

Perhaps you can get a photostat machine that will scan and email directly after the signature have been sent.

 

[Elynn]

There are softwares that replace ink signatures with digital signature or electronic signature which should meet your need... Google will provide you with some software available in the market...

 

[simonyeeklang]

There are softwares that replace ink signatures with digital signature or electronic signature which should meet your need... Google will provide you with some software available in the market...

Perhaps those lawyer also wants a hard copy instead of softcopy but I think both hard copy and soft copy is important.

 

[yodon]

Yes we will be doing the same "printing a hard copy of the pages with signature blocks & revision history and then "wet ink" signing" and in order to link to an electronic record we will provide electronic record unique details ( like the name of the record, create/modify time and date, its size (in Kb, as it would appear on the computer), format (pdf)). After this time to time manual audit trails will be conducted to prevent any unauthentic changes to the records.

Audit trails (my understanding, at least) are not "conducted." Audit trails are data collected about documents (who changed, when changed, etc.). Audit trails cannot prevent unauthorized (or unauthenticated) changes. That's a security function.

Maybe it's due to being Monday or just me being dense, but I still don't see how a "wet ink" signature can be linked to an electronic record. It's too easy to manipulate all the elements you mention above.

The audit trails will be signed and maintained in separate and parallel paper records.

There are no requirements for audit trails to be signed. I think you're way over-complicating matters here. Audit trails do need to be validated. A hardcopy of an audit trail is, IMO, not worth anything.

The audit trails will be conducted in our sister branch in country B. Now the audit trail records, signed pages will be sent on the mailing address of our main branch in USA (here I guess we can use fax?) and the complete 510k submission documents will be emailed to us in USA by our sister branch in country B, we in USA will take print outs ( or you would suggest that we should ask our sister branch in country B to take print outs of the complete 510k submission documents and send them to us through fax?). Finally we submit all documents to FDA with the signed pages and audit trails. Will this be acceptable? OR would you suggest to adopt any alternate method?

Can you please suggest any way to include the signature of the consultant who in country A? OR We should keep the documents just between us in USA and our sister branch in country B and skip the signature of consultant because that might make our compliance complex, as we will then have to be concerned about our interaction with the consultant (as we sent him all the documents through email and he sent us all the reviews through email).

First off, what do your procedures say? If the consultant is not required by your procedures to sign then don't do it. We (as consultants) often don't sign documents for our clients despite involvement we have on them.

So my suggestion is to first see what you can do to simplify the process. Look at the regs and look at your procedures and determine just what's necessary. Then, if you want to stick with manual signatures, device a process to capture those in hardcopy. If you want to go all electronic, there are plenty of systems, as Elynn notes, that can be fully compliant with the regulations (of course, you have to use them in a compliant manner and validate them as such).

 

[The Specialist]

The easiest way to handle this situation would be to have all of the document reviewers/approvers in the same place.

The 'wet signature' document, when operating a hybrid system becomes the 'master' document and must be treated as such, so I am not fully sure what you are trying to do with "linking to electronic records".


Of course, if you need to have multiple sigatories in multiple geographic areas , then moving to a 21 CFR pt11 compliant electronic system is the best way.
You will not have any more of these issues then!

 

[Jennifer27]

I'm learning about FDA and compliance please excuse my mistakes. I think with the input given by all the experts I'm now able to understand the process of compliance. Thanks Yodon, Specialist, Elynn and Simonfor the input,Kindly have a look at the following:



We actually have all our reviewers/approvers in the same country B (we will skip the consultant).

So, we have all the people working on the documents in the same geographic location i.e. country B, they will prepare records electronically, take print outs of the electronic records and after signing, treat the records as master records or master plans which can be executed. They will exercise control on the documents, by limiting the access to the system, where all the documents are stored, only to authorized individuals. They will demonstrate that the print out (which has been signed and used as master records) is the exact representation of the electronic document on system.

Finally, all these signed hardcopies will be sent to us in USA (on our mailing address), in a controlled manner, and we will simply submit it to the FDA.

Is this method right?

 

[The Specialist]

I'm learning about FDA and compliance please excuse my mistakes. I think with the input given by all the experts I'm now able to understand the process of compliance. Thanks Yodon, Specialist, Elynn and Simonfor the input,Kindly have a look at the following:



We actually have all our reviewers/approvers in the same country B (we will skip the consultant).

So, we have all the people working on the documents in the same geographic location i.e. country B, they will prepare records electronically, take print outs of the electronic records and after signing, treat the records as master records or master plans which can be executed. They will exercise control on the documents, by limiting the access to the system, where all the documents are stored, only to authorized individuals. They will demonstrate that the print out (which has been signed and used as master records) is the exact representation of the electronic document on system.

Finally, all these signed hardcopies will be sent to us in USA (on our mailing address), in a controlled manner, and we will simply submit it to the FDA.

Is this method right?

That sounds perfect!