HI all,
I too had this question so I asked the FDA, specifically CDER. Figured that was the fastest way to the right answer. This is the response I received today:
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Thank you for your inquiry regarding electronic signatures and signature certifications. Provided you use a system that satisfies Part 11 requirements for electronic signatures, these signatures may be used to replace traditional handwritten signatures.
Regarding 21 CFR 11.100(c), you may submit a general letter of certification on behalf of your entire organization for employees, agents, or representatives to the Agency to indicate all electronic signatures are equivalent to traditional handwritten signatures. This general letter may cover investigator sites, institutions, or hospitals. Please see a sample template below.
Re: Electronic Signature Certificate Statement
To Whom It May Concern:
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [Company Name], intends that all electronic signatures executed by our employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of the traditional handwritten signatures of individuals whose identity [Company Name] has verified.
Sincerely yours,
[Handwritten signature]
[Name of Company Representative]
[Company Representative Title]
In addition, please note that the appropriate mailing address for this certification is
FDA (OHAFO – DHAFOB)
ELEM RM2133 HFC-1
12420 Parklawn Drive
Rockville, MD 20857
The information provided in response to this inquiry does not address any specific product or trial. Follow-up questions regarding specific products or trials should be directed to the appropriate FDA review division by the sponsor.
Thank you
Ref OMP5291
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Best
Leslie Dow
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Leslie Dow
East Moline IL
United States
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Original Message:
Sent: 12-Jun-2019 12:52
From: Anonymous Member
Subject: 21 CFR Part 11
This message was posted by a user wishing to remain anonymous
This is regarding Part 11 Subpart C- Electronic Signatures. In Section 11.100 General Requirements (c)
c) 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.
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.
(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.
A company currently does not sell in the US but has plans to do so in the future. It would still like to be part 11 compliant to ensure its QMS will meet the regulatory requirements of FDA. In this case, does it make sense to certify to the agency even if it currently does not sell to the US? Thanks.