Quote from Jeanette on May 11, 2022, 11:55 pm
Only those that want to submit documents through the ESG would need submit the letter of Non-Repudiation Agreement as part of the registration process. I don't think many sites would have a need to be a part of this process; maybe some academic sites for reasons I am unaware of.
However, the letter the ESG is referring to is something that should each organization should be aware of prior to implementing electronic signatures, regardless of the relation to the ESG.
If your organization is/will be using electronic signatures,- a letter of Non-Repudiation will need to be submitted to the Office of Regional Operations.
Per 21 CFR Part 11 Subpart C Section 11.1, organizations are required to notify the Office of Regional Operations (HFC-100) in writing about their intent to use electronic signatures, prior to or at the time of such use, and 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.
Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11/subpart-C/section-11.100
I am happy to upload a template of the letter we used for submission, and the FDA has sample letters as well that can be used.
Only those that want to submit documents through the ESG would need submit the letter of Non-Repudiation Agreement as part of the registration process. I don't think many sites would have a need to be a part of this process; maybe some academic sites for reasons I am unaware of.
However, the letter the ESG is referring to is something that should each organization should be aware of prior to implementing electronic signatures, regardless of the relation to the ESG.
If your organization is/will be using electronic signatures,- a letter of Non-Repudiation will need to be submitted to the Office of Regional Operations.
Per 21 CFR Part 11 Subpart C Section 11.1, organizations are required to notify the Office of Regional Operations (HFC-100) in writing about their intent to use electronic signatures, prior to or at the time of such use, and 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.
Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11/subpart-C/section-11.100
I am happy to upload a template of the letter we used for submission, and the FDA has sample letters as well that can be used.
