21 CFR Part 11 - Electronic Signature Certification

C

Copacetic

#1
21 CFR Part 11.100(c) states:

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

I am hearing that this is not generally adhered to by medical device manufacturers and is not enforced by the FDA. I would love to hear thoughts on this.
 
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G

Gert Sorensen

#3
21 CFR Part 11.100(c) states:

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

I am hearing that this is not generally adhered to by medical device manufacturers and is not enforced by the FDA. I would love to hear thoughts on this.
I have no doubts that you can find lots of manufacturers who does not adhere this part of 21 CFR Part 11. One does get the impression that most manufacturers implementing an electronic signature does not read Part 11 prior to implementing it, and sadly, neither does the companies supplying the signature solution.

The issue is of course, that Part 11 is rarely in the scope of an FDA inspection (they call it enforcement discretion), and since Part 11 is not in the scope companies tend to overlook things like this.

I do not recommend that one skips lightly over this; a worst case interpretation by an inspector could mean that you were non-compliant on all the electronic signatures used in a system.
 
Y

yeshpal

#4
21 CFR Part 11.100(c) states:

Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

I am hearing that this is not generally adhered to by medical device manufacturers and is not enforced by the FDA. I would love to hear thoughts on this.
As per my understanding, If the established system is said to be 21 CFR part 11 compliant then there should be sufficient objective evidence apart from agency notification (prior to or at the time certify FDA) but definitely certify to agency that the signatures with appropriate delegation/scope are legally binding any time (or atleast already established timelines).

Thanks & Regards,
Yeshpal Mathangi :agree1:
 
A

ariannas

#5
I'm curious -- has anyone who has sent the certification to the FDA received a reply from the FDA?
 
U

UncleCrazyHorse

#8
Bumping an old thread.

ariannas,
For the benefit of the unfamiliar, could you expand on the dialogue with the FDA?
  1. What did you send to them? (overview)
  2. What was the lag between your submittal and the reply?
  3. What did they include in their reply? (Summary)

Thanks in advance.
Other responses from those with similar experience is encouraged as well.
 

Mark Meer

Trusted Information Resource
#10
...but I never got a reply.
Don't hold your breath. From the link you posted:
"...organizations need not await FDA?s response before putting electronic signature systems into effect..."

Obviously the response, if any is coming, is very low priority.

BTW: thanks for the posted link. This is an interesting read. Recommended for anyone who (like me) still need some clarifications on 21 CFR Part 11. :read:

In particular, I was always curious why they included the requirement for the certification. Afterall, it's just a sentence, only needs to be signed by one person, and doesn't need to detail any information about the system itself. ...from the link, I see now that it is purely for legal purposes:

"...FDA believes it is vital to have such certificates, as a matter of record, in advance of any possible litigation."

I have to wonder though, if a certification is sent, does this make it more likely that 21 CFR Part 11 compliance might be included in the scope of future FDA inspections? :(
 
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