A
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!
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!