We are working at a small manufacturing company which is in the process of implementing a QMS according to ISO 9001.
Our question is about the need of a signature on procedures and work instructions. Even if most of the personnel have access to the quality documents on our Intranet some persons don’t and our solution to this problem is to give them a folder consisting the quality documents needed. Is it enough to have a signed copy of each document in a master copy folder or does every copy distributed in the organisation have to be signed to ensure that the document is valid. It is a problem for us to get an electronic signature and therefor we wonder if it is OK to do it this way?
We look forward to your reply!
Hi,
I would say all documents need to be signed as authorised. Are you running a full Electronic Document Management System, which allow for e-sigs? If so this may allow not ving signed copies. If however you are using a home grown hi-bred, where you prepare hard copies (using a standard word processor, Word or Open Office) and get this signed, then do you electronically convert these to PDF without signaturesthen you may run into issues?
From my understaning of the EU GMPs, section 4.3 says that docs should be approved, signed and dated. Unless you have an EDMS which can control this I think you need to have a wet-ink signature on the master, and a scanned copy of the procedure on the intranet, and photocopies distributed to you satalite area’s.
I think that unless you do it this way you may find it hard to prove that there have been no changes made to the electronically converted version, other than the honesty of your staff, as per section 4.4 of the EU GMPs.
Regards
Rob