Document Approval per Sec. 820.40 (a) of 21 CFR part 820

somashekar

Staff member
Super Moderator
#1
Within Sec 820.40 (a) it reads thus :
The approval, including the date and signature of the individual (s) approving the document, shall be documented.

Can this be met with a printed date on the document say at the top of the page with the signature (s) at the bottom ?
OR
Does the date have to appear just below the signature perhaps written by the same person (s) signing ?
 
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Doug Tropf

Quite Involved in Discussions
#2
The QS regulation allows for the development and use of procedures that meet specific needs. What is important regarding change control, is that all changes be made in accordance with the approved company policy and procedure. Our documents have an effective date at the top of the first page and a date by the approving individual(s) signature.
 

sagai

Quite Involved in Discussions
#3
Can this be met with a printed date on the document say at the top of the page with the signature (s) at the bottom ?
Well, it is depend on how big the paper is.
It is okay if the paper fits well on the medium wedding dinning table I guess.

:eek:
Sz,
 

sagai

Quite Involved in Discussions
#5
If I would like to be 1oo% sure I am fine with the date in the header and the signature in the footer, I would define a template for the record/document and a clear definition in Document Management SOP, that the date in the header and what does the signing means in the footer, basically that is all. And of course I would not leave a gap for implementing the SOP.
br
Sz.
 
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