Requirement for Signature on Document

[Jen C]

Hello - we work in Medical Devices, under ISO 13485, EU MDR, 21 CFR 820 and numerous other country regulations.

We're working on updating our document control process, and QS would like to remove the requirement to have an actual signature on each document (i.e., there would be neither physical nor electronic signature).

Our documents go through an extensive document change process, and signatures are captured on the DCO form. The argument is that we can show documents are approved via the process and thus an actual signature is not required on the document itself.

I agree insofar as I can't find any specific requirement for a signature on each document, as long as we can show it's gone through an established approval process and we have signatures from the appropriate defined approvers. But in practical terms, I'm concerned this will lead to constant questions in audits and submission reviews about how we can show each document is approved if it doesn't have a signature on it. I don't want to be always having to show the DCO form to prove the approvals were obtained.

Has anyone successfully implemented a system without signatures on the documents themselves?

 

[Tagin]

21CFR820.40 Document controls

Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented.

...Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

I believe there may be the possibility to use electronic signatures as an alternative to handwritten ones, but I'm not certain.

 

[indubioush]

Has anyone successfully implemented a system without signatures on the documents themselves?

Yes. At most of the medical device companies I have worked for, the controlled documents do not have any signature. The document contains a reference to the change order number. The change order record contains the approval signature. There is absolutely no problem with this.

But in practical terms, I'm concerned this will lead to constant questions in audits and submission reviews about how we can show each document is approved if it doesn't have a signature on it. I don't want to be always having to show the DCO form to prove the approvals were obtained.

Yes, you will have to show the DCO to prove that the approvals were obtained. However, the auditor will not be asking for every DCO for every document they look at. They will do a sampling of your DCOs when auditing your document control and change control processes.

 

[silentmonkey]

Should be fine. Our documents don't have signatures on it. In some cases, I have seen "refer to XYZ for approvals" where XYZ can be a change order document or the audit trail in the electronic document management system.

 

[yodon]

I believe there may be the possibility to use electronic signatures as an alternative to handwritten ones, but I'm not certain.

There is... but in the US, that is governed by 21CFR Part 11 (the dreaded electronic records / electronic signatures regulation). They're still applying "enforcement discretion" so if you can demonstrate good controls, it's likely fine. (It's definitely worth a read if you plan on going this route.)

 

[Jen C]

Thanks all! Yes, we are implementing Part 11-compliant electronic signatures for other things (e.g., for the DCO approvals), but we don't want any signatures at all on the documents. It helps to know others have done this without too many issues. I'll likely suggest including a generic statement on the front page of each document stating something like "approval signatures are documented on the DCO form in accordance with SOPXXX" in an attempt to head off too many questions, but I'm sure even that isn't necessary.

 

[indubioush]

"approval signatures are documented on the DCO form in accordance with SOPXXX" in an attempt to head off too many questions, but I'm sure even that isn't necessary.

It is actually quite helpful to the organization to have a revision history table with reference to each revision's change order. Not required, but this is typical.

 

[Lamesser]

I have worked for a number of global Medical Device and Pharma companies. I have yet to see any of them not have a signature page included as part of the released document. Not to say it can't be done other ways, but attaching a signature page to the document is the cleanest (Most EDMS do this automatically nowadays). How you deploy your DCOs? Consider if a DCO will contain multiple documents and if those documents always have a uniform approval matrix or different approval matrices (in other words, do all approvers of the DCO approve all attached documents or only those pertinent to them/their department/function). If not uniform, then how will you document who approved which document? Depending on the size and complexity of your company, perhaps the same functions approve all documents today, but as you grow, this seldom remains the case. Plan for growth and design for the future.

During an audit, the auditor always wants to know who reviewed/approved a document. They may also want to know the meaning of a signature (ie: approver, technical reviewer, etc.). Whatever you do, be certain that the approval process clearly documents who approved which documents.

Lastly consider this; If you always have to produce a DCO to document the approvals, will this practice ever lead the auditor on a "fishing expedition"? If all they want to know is if the appropriate functions approved a document, do you need to give them more information than what they ask for and possibly lead them down another path of investigation because of something that catches their eye in the DCO?

 

[indubioush]

How you deploy your DCOs? Consider if a DCO will contain multiple documents and if those documents always have a uniform approval matrix or different approval matrices (in other words, do all approvers of the DCO approve all attached documents or only those pertinent to them/their department/function).

They approve all documents in the DCO. Signature matrices show minimum required approvers.

will this practice ever lead the auditor on a "fishing expedition"?

There is a chance of that, but this has never been an issue for me and nor is it a fear. I would much rather show approvers through the DCO alone rather than go obtain final signatures on my final document after the DCO has been approved. Now I have a question for you. Do your approvers also sign the DCO or do they just sign the document?

 

[Lamesser]

They approve all documents in the DCO. Signature matrices show minimum required approvers.


There is a chance of that, but this has never been an issue for me and nor is it a fear. I would much rather show approvers through the DCO alone rather than go obtain final signatures on my final document after the DCO has been approved. Now I have a question for you. Do your approvers also sign the DCO or do they just sign the document?

It depends on the system being used, but most often the approvals are on the documents. The most recent Agile based PLM system uses the CR/CO approach (CMII). First a Change Request (CR) is created wherein the entire change is scoped out, impact assessment performed and documented, implementation plan created, SME input gathered, costs estimated, etc. The CR is approved. Then one or more change orders (CO) created to execute the change. The revised documents are signed then. COs also assign and track implementation activities to completion.

By the way, if your documents contain extensive change history tabulations, this can lead to auditor "fishing expeditions " as well. I have seen it happen. Just a word to the wise....