Title: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science Meeting 23 October 2002, 8:30 a.m.
1DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and
Drug AdministrationProcess Analytical
Technologies Subcommittee of the Advisory
Committee for Pharmaceutical Science Meeting23
October 2002, 830 a.m. 500 p.m.Re 21 CFR
Part 11 Electronic Records Electronic
Signatures
2 Regulation Commentary
21 CFR 11.70 Electronic signatures and
handwritten signatures executed to electronic
records shall be linked to their respective
electronic records to ensure that the signatures
cannot be excised, copied, or otherwise
transferred to falsify an electronic record by
ordinary means.
This requirement appears onerous because it
requires a person to compare the handwritten
signature with the electronic signature or it
would require an expensive, complex system to
meet this requirement.
3 Regulation Commentary
- 21 CFR 11.100 (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. - The certification shall be submitted in paper
form and signed with a traditional handwritten
signature, to the Office of Regional Operations
(HC-100), 5600 Fishers Lane, Rockville, MD 20857.
It is unlikely that we would be able to
implement this requirement and keep up to date
for all individuals due to changes in personnel.
4 Regulation Commentary
- 21 CFR 11.200 (a)
- Employ at least two distinct identification
components such as an identification code and
password.
In the event the actual data in the computer
system cannot be modified by the users, we
believe one distinct identified component such as
an identification code or password would be
sufficient.
5Thank you