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Operator Initialling on Paperwork - FDA Good Documentation Practices

I

inspector1

#1
Hello,

I was wondering if there is any documentation requirements for operator initialling on paperwork. Some of my operators circle their initials and i was wondering if a circled inital meant anything other than just putting your initals down.

We are FDA certified. If anyone has any links to any info to some sort of document that has this in it, please let me know.

Thank you for your help.
 
#2
Re: Good documentation practices. Initialing.

Welcome to the Cove, Inspector 1! :bigwave:

Since you are FDA, it would be helpful to provide more information as to what the operators are initialing. There is a possibility that there is no requirement (other than internal to your company) for them to sign, or initial.

As far as circling their initials, I do that. Why... I really don't know. I just always have. There is no distinction I can recall in FDA rules for circling or not, and again, I don't know if your company makes a distinction. My guess is it is just the way they do it. A distinctive flair, I guess.

Let's see what other Covers have to say.
 

somashekar

Staff member
Super Moderator
#3
Re: Good documentation practices. Initialing.

Hello,

I was wondering if there is any documentation requirements for operator initialling on paperwork. Some of my operators circle their initials and i was wondering if a circled inital meant anything other than just putting your initals down.

We are FDA certified. If anyone has any links to any info to some sort of document that has this in it, please let me know.

Thank you for your help.
Welcome here ...
I have moved this thread to "Other US Medical Device Regulation Topics" subforum for more appropriate hits, since the OP mentions that they are FDA certified..
 
S

silentrunning

#4
We got away from initials and use ruber stamps now. No real reason other than it is hard to forge someone elses stamp.
 
I

inspector1

#5
I found my answer for anyone that wants to know in FDA

Title 21, Chapter 1, Subchapter H - Medical Devices
Part 820-Quality System Regulations
Subpart D. Document Controls

Sec 820.40 Document Controls.

Thank you all.
 
#6
The requirement you referenced is for document creation and approval, not on operators initialing that they completed a task. Of course, I might have misunderstood your initial post. Usually, operators don't create documents. I am also not sure just initialing the document meets the requirements for signature and date (although, I suppose that could be argued).
 
#7
I found my answer for anyone that wants to know in FDA

Title 21, Chapter 1, Subchapter H - Medical Devices
Part 820-Quality System Regulations
Subpart D. Document Controls

Sec 820.40 Document Controls.

Thank you all.

You'd need to be looking at 820.80 (e). As previously noted , 820.40 has nothing to do with your inquiry.

The intent of the acceptance sign-off is that the person doing it can be readily identified. The standard talks about signatures, but what is meant by this is that a unique and clear identification method is required; yes, signatures are unique and have been used for years as a means of proving that the signer is the owner of a signature, but they often cannot be read - at best, they're used by comparison to a known sample that are alongside a printed name or photo. Banks still do this. Look at the back of your credit cards - we've been taught that the more cryptic the signature is, the better. Not so for the records in question at all! For records, we're not worried about forgery, we're worried about lack of legibility.

I can recognize my signature in an instant, but I highly doubt I could tell your name by looking at yours. On top of that, hardly anyone's signature represents their full name.

If you are audited and the auditor finds any evidence that an initial or signature is ambiguous, illegible or unclear, there will likely be a finding. The identification of the person who signed off on that operation must be clear to everyone, not just the operator and people that are familiar with the owner of that "scrawl". Initials are no better.

Stamps are the way to go. They are controlled, legible and consistent.
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#8
The best way system I have seen is to have signature cards on file (like a bank). It has your official name, signature, initials and stamp if you use it. Some companies use this system to list official delegates for the signatory. Just a thought.
 
M

MIREGMGR

#9
The intent of the acceptance sign-off is that the person doing it can be readily identified. The standard talks about signatures, but what is meant by this is that a unique and clear identification method is required; yes, signatures are unique and have been used for years as a means of proving that the signer is the owner of a signature, but they often cannot be read - at best, they're used by comparison to a known sample that are alongside a printed name or photo. Banks still do this. Look at the back of your credit cards - we've been taught that the more cryptic the signature is, the better. Not so for the records in question at all! For records, we're not worried about forgery, we're worried about lack of legibility.
Well, legally, yes and no.

Sometimes when FDA uses the word "signature", they are using it in its legal sense. A "signature" is a legal commitment by the signer that they read, or did, or agreed to whatever's contained in the document they have signed.

That's why a bank check requires a signature, and the bank won't be happy if you use a rubber stamp unless you've arranged with them in advance to their satisfaction that the particular stamp you want to use legally comprises a signature. Ditto with a prescription form and a rubber stamped signature.

And note that in regard to the legal significance of a signature, readability isn't relevant. Many doctors' signatures are completely illegible. They must teach that in medical school.

This metaphysical-legal significance is why 21CFR 11, and FDA in general when they're focused on responsible approvals, makes such a big deal about signatures.

Initials--actually, a recognizably personal initial-object, not just the right set of two or three letters affixed in some manner other than handwriting--sometimes can be a legal signature, if they're so intended and that's understood to all concerned parties.

The second best approach to the use of initials in an organization that has FDA obligations for record signature is to have a signature card or log for each individual that may need to sign an FDA required record, and have each such individual's script signature and recognizably personal initial-object on the card or log. That's the approach that is used where I work. The first best way is to have such a signature card or log, and limit everyone to the same full signature that they would use to sign a check.

Other times, the above quoted analysis is correct, and the point of a signoff is just to identify who did the work. In those cases, a rubber stamp is fine.
 
#10
That's why a bank check requires a signature, and the bank won't be happy if you use a rubber stamp unless you've arranged with them in advance to their satisfaction that the particular stamp you want to use legally comprises a signature. Ditto with a prescription form and a rubber stamped signature.
I'm not talking about a rubber stamp signature. I'm talking about a company issued identification stamp - EID, Group, etc. For example, mine says QAA-1197.

Having your signature replicated into a rubber stamp is pointless - it's even worse than a handwritten one, because then it could be used by anyone.
 
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