Hi Rashmi,
21CFRPart11 should be applied any time an electronic signature is used in place of a wet-ink signature. Here is an example. We use electronic signatures in MasterControl; the user enters their username and an "electronic signature" (like a password) to electronically approve standard operating procedures and other quality events.
Before a user's account is set up in this system, they provide a wet-ink signature on a following document with the following statement:
"By signing this form, the Employee listed below is certifying that they understand that His or Her Electronic Signature (i.e. Unique User ID and Approval Password) is to be considered as a legally acceptable and functionally binding equivalent of their paper-based signature.
They are also certifying that they shall:
- Protect their passwords at all times. They shall not:
-
- Share, post, circulate passwords or access security credentials
- Cut, paste, modify or alter e-signatures
- Report compromised electronic signatures and/or lost laptops to their managers and IT as soon as possible.
- Report any suspected misuse of their password.
- Be accountable for any actions to which their electronic signature is applied.
- Answer any questions about their application of an electronic signature when asked by a regulatory authority."
We scan and store these completed forms electronically for review by regulatory agencies upon request. Hope this helps clarify the requirement a bit.
Best,
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Kelly Dolezal
Savoy IL
United States
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Original Message:
Sent: 01-Aug-2018 00:11
From: Rashmi Pillay
Subject: Electronic signature
Hi ,
Can anybody clarify the requirements under 21 CFR Sec C Part 11.100 , what does this requirement pertain to and what is required?
(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.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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