§ 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as an identification code and password.
(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
How BatchGlow handles this
Signing asks again for the signer's password or signing PIN at the moment of signing; it is never carried over from the login. Batch release, assay compensation, line clearance and weighing accept only the enrolled PIN.
What it asks for, in plain words
- 21 CFR 11.200
- An electronic signature not based on biometrics has at least two distinct parts, such as an identification code and a password. The first signing of a continuous session uses all parts; each later signing in it uses at least one part that only the signer can execute and that is meant to be used only by the signer; a signing outside such a session uses all parts. Only its owner uses it, and anyone else would need two or more people working together to use it. A biometric signature can be used only by its owner.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.