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FDA 21 CFR Part 11 "Meaning of Signature"

QIE

QIE

Registered
#1
#1
We're in the process of moving from paper based document control to electronic. In looking at Part 11 compliance, Subpart B, Section 11.50 (a) states:
Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

My question is on (3): is it sufficient that the electronic record shows, for example, that John Doe "approved" the document or is it required that his role or job title is also included on the record?
 
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Ronen E

Ronen E

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Staff member
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#2
#2
What clause in Part 11 (or elsewhere) makes you think the role or job title also needs to be included on the record?
 
QIE

QIE

Registered
#3
#3
I'm referring to Part 11, Subpart B, Section 11.50 (a) (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. I have heard opinions from others (not FDA) that the role of the person or the role as related to a particular document must also be captured. The electronic system captures the approvals but doesn't actually capture on the record the title of that person or their role at the time. The audit trail shows who initiated the change or the new document, who the approvers are and when they approved. I'm hoping this is sufficient?
 
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pkost

Trusted Information Resource
#4
#4
If the regulations do not require it (and you have not heard any suggestions contrary to this from the FDA) then it is not a requirement. What relevence does the title have? The questions that need to be asked are:
- Who signed it?
- what were they doing? e.g. approving
- were they competent/appropriate to sign off

A title does not demonstrate competence
 
QIE

QIE

Registered
#5
#5
Thanks for the feedback. I guess what was throwing me was the word "responsibility" in the FDA statement: Part 11, Subpart B, Section 11.50 (a) (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
 
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pziemlewicz

Involved In Discussions
#6
#6
Usually this would be covered under Authority and Responsibility and/or Control of Documents and Records. Somewhere in your system, you should identify who has the authority to sign off on the different documents required.

Another easy way to cover this would be to label the signature line on the form. For example, a test report may require signature of Engineering Manager on the record.
 
QIE

QIE

Registered
#7
#7
Thank you pziemlewicz. That is a good point - we do have an approval matrix for the various documents and that should cover it.
 
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