Hi,

I am currently implementing a system for document control with the possibility to electronically sign documents (by adding a scanned graphic of a handwritten signature and the date of signature set by the system).

Up till know, my idea has been that once a document is considered "finished" is is locked for further editing and sent to the respective reviewers for signing.

The problem arises when I want to add a scanned signature and the date of the signature as part of the header of the document. In order to do so, I would need to remove the "read only" tag from the document.
Technically, the document is altered each time I add a signature and a date, so strictly speaking, the signatories are all signing "different" versions of the document. There is no guarantee that the signatories did not alter anything else in the document apart from adding their signature.


Does anyone else experience the same "problems"? How did you go about it?


best regards
t.

Hi Temuijn,

What program are you trying to use for this feature?

:bigwave:

I would say dont add a scanned signature to an electronic document as evidence of authorisation as its a nonsense.

I think you either have to go full bore electronic and have database approval/integrity, or go full paper based and have old signed copies, or go semi-electronic and print a master get is signed and scanned and use the scanned signed copy for distribution.

I often wonder what is trying to be achieved by putting a scanned signature on a document. There is no requirement in ISO 9001 for a signature on controlled documents - just approval. Don't pretend, use a method of approval that doesn't require any signatures and make life easy:) I am sure there are numerous previous threads containing methods of doing this.

I am using PDM Works Enterprise from solid works for Document Management. The documents contained will mostly be Word Documents as well as Solid Works documents.

Unfortunately, lots of authorities, especially asian ones, seem require documents signed the old way, that´s why we need to apply this kind of signature.

Might go for the semi-electronic solution though...

btw, we are in the medical device intustry.

thanks,

t.

btw, we are in the medical device intustry.

thanks,

t.

I don't know if your company sells product in the US, but if so, then you will also need to review CFR Part 11 for Electronic Records and Electronic Signatures. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm There may additional requirements to consider.

Just a thought. We currently use a semi-electronic system for document control, which is not exactly ideal, but it works for us. :) Good luck, temujin. :bigwave:

Thanks, we also distribute in the US.
Actually the FDA is not a big issue as they have a more procedures for how to accept electronic signatures, as you mention in CFR 21 part 11.

The biggest problems are with some countries in the Asian marked in which the traditional signature is the only valid signature.

t.

I presume you refer to Word documents. There is no fool prof way with Word. One possible workaround is to lock the document for tracked changes (with password). This way any change (including the added signatures) would show as changes in the document

I assume you are sending the documents around via email and the approvers are inserting their scanned signatures. Is this correct?

In addition to Wally's suggestion (which is a good one), both MS Word and OpenOffice allow you to compare different versions of documents. So after your document has gone through the chop chain you can compare the one you sent around for approval with the one you got back. The only changes you should see would be the inserted signatures.

I assume you are sending the documents around via email and the approvers are inserting their scanned signatures. Is this correct?


not quite. The documents (MS Word, Open Office, Solid Works Drawing etc), are all checked into a closed system (PDM Works) which limits the users access to modifying the docs. All actions involving approval/disapproval are done within this program. In case I would use scanned signatures I would store the signatures on the server and have them automatically inserted when people approve of documents...

But...From what I have heard so far, I think I will leave out the scanned signatures and leave some space for manually signing the documents in case somebody would require it.

regards
t.

We used a very simple and effective word template for approval by predefined responsible departmental personal. This master document approval is electronically send out via e-mail when the final draft is ready for approval. We haven't experienced any problem for the past three years.

Hope this helps!

Eric Ng

Another system I have used successfully is to attach a signature page to the document. That way the original document can be locked for editing while it is being routed for approval. Each approver or reviewer can either physically sign the signature page or place a scanned signature on the signature page. If you need an approval statement in the document header, you can type in the statement: Original approved by: XXXX. The signature page simply contains the document name and number, Revision number, date and signatures.

Hope this helps.