21 CFR 11.100: General requirements
Requires each electronic signature to be unique to one person and never reused or reassigned, organizations to verify identity before issuing it, and users to certify to FDA it equals a handwritten signature.
Part 11, Electronic Records; Electronic Signatures · Subpart C, Electronic Signatures
Recent 483s citing 11.100
- Faencal Tartaric Products, Inc · Fresno, CaliforniaThere is a failure to establish electronic signatures unique to each laboratory… Mar 29, 2016
- Utah Medical Products · Midvale, UtahThe firm has yet to certify to FDA that the electronic signatures in their system… Jul 23, 2015
- Utah Medical Products, Inc. · Midvale, UtahThe firm has yet to certify to FDA that the electronic signatures in their system… Aug 1, 2001
The regulation text
§ 11.100 General requirements.
(a)Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
(b)Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.
(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 signed with a traditional handwritten signature and submitted in electronic or paper form. Information on where to submit the certification can be found on FDA's web page on Letters of Non-Repudiation Agreement.
(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.
[62 FR 13464, Mar. 20, 1997, as amended at 88 FR 13018, Mar. 2, 2023]
Questions
What does 21 CFR 11.100 require?
Requires each electronic signature to be unique to one person and never reused or reassigned, organizations to verify identity before issuing it, and users to certify to FDA it equals a handwritten signature.
Which sections are cited alongside 11.100?
In the same 483s, investigators most often also cite 11.10 (Controls for closed systems), 820.100 (Corrective and preventive action), 820.184 (Device history record), 820.80 (Receiving, in-process, and finished device acceptance).