Document Review and Document Approval --- 2 Signatures needed acc. §820.40?

Aphel

Involved In Discussions
#1
Dear all,
A short question came up here during implementing a document control system.

§820.40 requires to review amd approve documents.
But only the approval has to be confirmed with signature.

What if review and approval is performed by two different individuals? Is also the review to be confirmed with signature?

The regulation does not exactly specify.... so how to cope with that?

Thanks in advance!
Best regards, Aphel
 
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Aphel

Involved In Discussions
#3
Hello Yodon,
You are right. Of course.

But from your point of view - in case there are 3 persons involved... 2 of them do only a review of appropritateness and 1 performs the approval.
Would you mind the regulation requires 3 signatures?
 

yodon

Staff member
Super Moderator
#4
The regulations / standards don't dictate by whom or how many signatures are applied. That's up to you. Of course, whatever decisions you make as to who approves should be defensible (they have the appropriate knowledge, background info, authority, etc.). If you're worried about having objective evidence of reviews beyond that of the approver(s), that can be accomplished in a variety of ways (although I have never had an auditor / inspector ask). If you have an eQMS system, often reviewers have to indicate (which is captured) they reviewed (to enable movement to the next stage). If you route for reviews, you could capture redline docs as part of the review. Or you could document the review (record) saying who participated and what the results were. Like I said, though, I've never had an auditor / inspector ask for such (I've always said that the approver, at least reviewed) but if you feel more comfortable with additional support, you can get creative.
 

Tidge

Trusted Information Resource
#5
Typically: 21 CFR 820.40 is implemented with a minimum of two approvers:
  1. One person is approving the adequacy of the change per 820.40(a) <- This is usually 'area owner'
  2. One person is approving the appropriateness of the document's release/revision per 820.40(b) <- This is usually 'Quality'
Both approvals have to be captured via signature (with all that implies).

You can try to make a case that the same person is filling both roles, but often this is not the case. You do not want to find yourself in an embarrassing situation where some change occurs and the 'area owner' says that they didn't approve the change that (only) quality signed off on.
 

qualprod

Trusted Information Resource
#6
Dear all,
A short question came up here during implementing a document control system.

§820.40 requires to review amd approve documents.
But only the approval has to be confirmed with signature.

What if review and approval is performed by two different individuals? Is also the review to be confirmed with signature?

The regulation does not exactly specify.... so how to cope with that?

Thanks in advance!
Best regards, Aphel
The standard doesn´t require signatures, is up to you.
The important thing is to review and approve.
Preferably on person can review and a different person can approve the document.
you can define that both can write down the signature or just the approver ....or....
just to upload your document to your QMS with only showing the name or position
of the reviewer and approver and keeping evidences of such actions (review and approve), they can
be an email kept somewhere in the QMS.

If you have a procedure for the control of documents, into it
you can describe these activities.

Hope this helps.
 

Tidge

Trusted Information Resource
#7
The first place to be consulted about questions in scope of 21 CFR part 820 should be the preamble.

I suggest a review of Preamble comments 94ff, specifically:

94. Several comments on proposed Sec. 820.40(a), ``Document approval and issue,'' as well as other sections throughout the regulation, suggested that the term ``signature'' be replaced by the term ``identification.'' Such a change would allow for electronic or computerized identification in lieu of formal written signatures. Other comments stated that ``or stamps'' should be added after ``signature'' since they are legally recognized in some foreign countries. FDA is aware that many documentation systems are now maintained electronically, and is in the process of developing an agency-wide policy that will be implemented through rulemaking on the use of electronic signatures. The agency identified several important issues related to the use of such signatures, including how to ensure that the identification is in fact the user's ``signature.'' These issues are discussed in FDA's ANPRM on the use of electronic signatures, published in the Federal Register on July 21, 1992 (57 FR 32185), and the proposed regulation published in the Federal Register on August 31, 1994 (59 FR 45160). Therefore, FDA has not revised the regulation to use the term ``identification,'' but notes that the quality system regulation's use of the term ``signature'' will permit the use of whatever electronic means the agency determines is the equivalent of a handwritten signature. FDA recommends that manufacturers use the two Federal Register documents as guidance until the regulation is finalized. FDA has not added the term ``or stamps'' to the regulation; however, stamps could be acceptable if the manufacturer has a formal procedure on how stamps are used in place of handwritten signatures. The procedure would have to address many of the same issues addressed in the electronic signature Federal Register documents, most importantly how the stamps would be controlled and how the manufacturer would ensure that the stamp was in fact the user's ``signature.''
 
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