Could We use electronic signatures rather than manual sign offs?

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ISO1234

I just had an ISO 13485/9001 audit. at the end of the audit I asked the auditor if we could use electronic signature rather than manual sign offs for each operation. She mentioned that there is nothing in ISO that says you can't. She was trying to find the section, but was unable to. She said that as long as we are signing our shipping papers assuring the quality of the product, then that was sufficient. Can anyone help me with the section number and some hard facts about this.

Right now we have a work traveler and each operation is signed off manually. We are switching over to a new system on the first of the year. This system allow the traceability of each operation by each employee signing on and off each operation on the computer. The traceability of the product will be printed when the job is complete and inserted into the Device History File and then Filed.

Everything will be the same as the traveler we have now except the sign offs will be printed and not manual.

Thanks,
Steve.
 
A

achorste

Are you under obligation to work to FDA's systems as well? In which case you would have to validate the system for electronic signatures, it would be best practice anyway, but 13485 doesn't call for it specifically (I think - don't have the standard to hand - someone may correct me on this).

I know of a few company's that use electronic signatures (they come under both FDA & 13485) and they've had no problems with it (from the regulatory side of things anyway).
 
I

ISO1234

I have not seen anything in the ISO regulations about this. My auditor knew of part of it, but could not find it at the moment. She made mention to when you ship a product you we are signing of quality on it. There is an IRS (inspection record sheet), this will have all the first pc, in process and final manual sign offs showing the control of manufacture for the device. We are just looking at the time electronic sign off of the traveler of which will also be signed off in the end. It just seems redundant to have multiple sign offs on each operation.

Thanks again,
Steve.
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
I have not seen anything in the ISO regulations about this. My auditor knew of part of it, but could not find it at the moment. She made mention to when you ship a product you we are signing of quality on it. There is an IRS (inspection record sheet), this will have all the first pc, in process and final manual sign offs showing the control of manufacture for the device. We are just looking at the time electronic sign off of the traveler of which will also be signed off in the end. It just seems redundant to have multiple sign offs on each operation.

Thanks again,
Steve.

I am not a medical device person, so I can't answer the question in the context of ISO 13485.

In the AS9100 world we sign each operation off to show evidence that the previous operations were completed. But that is how our organizations does it. I don't believe there is anything in the AS9100/ISO9001 standard that requires "signing off" the previous processes.

How does you Quality Management System state about the "signing off" of the previous processes, if it states anything at all? That is where it would state it is or is not required. Just my opinion.
 

Big Jim

Admin
Also, in ISO 9001:2000 (so it probably is in 13485 as well since ISO is the parent document) note 3 at the end of 4.2.1 says "the documentation can be in any form or type of medium". I believe this covers your acceptance media (electronic signatures) as well.

Since someone else mentioned AS9100, in the traceability section (7.5.3) additional mention of this is made. AS9100 enhancement says when you use approval media (stamps, electronic signatures, passwords) you need to establish and document controls for the media.
 
P

PMIN92618

Can you explain what is needed for the validation of signatures?
 
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