Do controlled documents require a signature on every page as per 21 CFR 820.40?

[ascherp]

One method of approving a controlled document such as a procedure is for the approver to sign the cover page and perhaps the footer on the first page of the procedure itself. The footer is printed out on the remaining pages, but not signed. This has been accepted by ISO 13485 auditors.

In your experience, does the FDA require every page of the original document to be signed? Or would the document control procedure described above fulfill FDA requirements?

(We're facing our first FDA inspection and would like to make sure.)

I appreciate any pointers!

 

[isoalchemist]

The requirement is that the document reviewed for adequacy and approved before it is issued. In my experience one signature (per approver) is required. As long as your procedure defines the approval process and is being followed you should be OK.

Of course I only had one approval block. Personally I would never have the approval block in a repeating footer showing up on multiple pages, because if it appears a signature should appear, in my experience the FDA tends to ask why it is missing. Make sure you cover this in your document control procedure (i.e. only page 1 is signed) and you should be covered.

 

[Ajit Basrur]

One method of approving a controlled document such as a procedure is for the approver to sign the cover page and perhaps the footer on the first page of the procedure itself. The footer is printed out on the remaining pages, but not signed. This has been accepted by ISO 13485 auditors.

In your experience, does the FDA require every page of the original document to be signed? Or would the document control procedure described above fulfill FDA requirements?

(We're facing our first FDA inspection and would like to make sure.)

I appreciate any pointers!

If you hard copies distribution, signature on page 1 followed by a stamp "Controlled Copy" on subsequent pages should be fine.

As mentioned earlier, the documentation control procedure need to spell the requirements towards a "controlled" documentation.

All the best for your FDA Inspection and do come back with your observations.

 

[Boingo-boingo]

I appreciate any pointers!

I would STRONGLY advise you against the creation of a bureaucracy nightmare. You have to balance the need for control/governance and the cost effectiveness of any process (including the document control process) that is part of your quality system.

I have seen some of the most convoluted and bureaucratic document control processes in the world, like, for example, each page of a document having it's own revision level...., each individual page being stamped and/or signed...

Don't allow yourself to fall into this type of mental trap, where you try to anticipate the most strict regulatory inspector's wishes.

You will have to live with the system, day in, day out. Don't overkill it.

 

[ascherp]

Thanks to all of you for saving us from overkill. Will let you know how it went!

 

[sagai]

Can I have a question how do you interpret and approach the record retention requirements?
Cheers!