Are signatures required on every page of a controlled document?

[DDTank]

Quick question: When preparing a controlled document such as an SOP, is it necessary for each and every page to be signed by the originator and authorizer (in a standard footer/header say with all the document control info), or is it enough just to have one set of signatures on the front page?

 

[pearson114]

The easiest way to do this is to have a header or footer with the Doc Ref, Page Number and Revision. If this information is on each page then just a signature on the first page would suffice.

If the approver has signed the front page at issue 3, and the remaining pages state issue 3, then the approver must have also approved the following pages.

 

[isoalchemist]

Only one signature is needed per document. Personal preference is I like a signature block on the last page with a revision history. What ever works for you is right

 

[Randy Lefferts]

Actually, signatures aren't required of ISO 9001 (you are posting in the ISO 9001 forum so am basing it on this). What is required is that they are approved. If you choose to do this with a signature, that is up to you. Seems that it is the accepted method of showing approval, but again, it isn't required. You just need to be able to show that the documents have been approved.

Now, if your internal procedures state that you approve documents by placing a signature on the document you do need to sign them. Signing the front page only would be acceptable as long as your procedure doesn't state otherwise. What does your procedure call out?

 

[pearson114]

At a previous company, the documents were 'electronically approved'. Meaning the name and title of the approver, and the document issue and ref number, and also the date of issue, were all electronically printed at the bottom of the page.

In order to convince the auditor of adequacy, we had a master register of documents with the current issue - the approver would sign the master register taking responsibility for the approval as per current issue of documents... if that makes sense.

 

[DDTank]

Interesting; thanks all. Current company requirements and practice are to sign off on the front page only. In a different industry we signed every page so I was considering implementing that but if it is not "necessary", I won't!

 

[TPMB4]

Judging by how a lot of people dislike signing anything I would keep it to as few signatures as possible. We prefer one set of signatures consisting of the originator and a second "checking" signature of someone who has the authority to approve said document. In our case directors, QM, Operations manager and a select few from other positions with relevancy.

I suppose a central register might be a good idea.

 

[tom haccp]

Our current document control practice is a cover page with preparer and approval signatures for all controlled documents such as SOPs, master forms, Quality Manual, safety plan manual and similar documents. Revision history is also on the cover page. Other pages have a header that indicates title, revision number, effect date and page number. All pages have file name. It is the same format that I have used in previous regulated companies.

I am interested in the "electronically approved" process. We have purchased document control software to allow us to eliminate the circulated folder approach; draft SOP with initiation paperwork passed from person to person for comments/changes, back to Document Control for incorporating changes, back out for final review and acceptance, and issuance of final version for sign off and posting (pdf posted for facility wide access, eliminated departmental SOP binders). Also linked our current SOPs through our Laboratory Information Management System (LIMS) so all analysts have immediate access only to the latest version of the SOP/method.

How does the "electronically approved" process work and are there any special requirements or issues? My concern is compliance to ISO 17025, FDA cGMP and third party auditor scrutiny.

Look forward to your comments.

 

[AndyN]

Only one signature is needed per document. Personal preference is I like a signature block on the last page with a revision history. What ever works for you is right

May I ask why? Documents don't need to be signed at all - physically or electronically...

 

[tom haccp]

Andy,

My lab falls under several different regulatory requirements and expectations of various client/third party auditors to show final official approval of any document (SOP, master form, quality or safety manual). Our tracking form used for initiation and review process is insufficient for formal approval.

If electronically approved, I'm looking for a solid compliant process to document initiation of the document, internal review and final approval. Anything else would be counter productive to an effective document control process.

I see final approval sign off as official authorization of that version of the document. Hoping to move toward electronic approval to comply with our paper-reduction and process streamlining plans.