An important part of 21CFR Part 11 compliance is Electronic Signatures. Electronic signatures are defined as a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. Electronic signatures that meet the requirements of 21CFR Part 11 are considered to be the equivalent to hand written signatures. Below is a partial list of requirements for using Electronic Signatures in compliance with 21 CFR Part 11:
*Requirement: *Signed electronic records must contain information associated with the signing that indicates the printed name of the signer, the date and time of the signing, and the meaning associated with the signature (such as review, approval, responsibility or authorship).
*Requirement: *Electronic signatures and handwritten signatures applied to
electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be removed, copied, or transferred to falsify an electronic record.
*Requirement: *Each electronic signature will be unique to an individual and
should not be reused by, or assigned to, another individual.
*Requirement: *Persons using electronic signatures shall certify to the FDA that they are using electronic signatures intended to be the legally binding equivalent of a traditional handwritten signature, and may be required to provide additional
certification that a given electronic signature is the equivalent of the signer's
handwritten signature.
*Requirement: *Electronic signatures not based upon biometrics should employ
two distinct identification components such as an identification code and password.
*Requirement: *When executing a series of signings during a continuous period,
the first signing should be executed using all signature components and subsequent signings at least one signature component.
*Requirement: *When an individual executes one or more signings not performed
during a continuous period, each signing should be executed using all of the electronic signature components.
*Requirement: *Electronic signatures shall be used by their genuine owners, and
be administered so that attempted use of an individual signature by anyone other
than its genuine owner requires collaboration of two or more individuals.
. The Electronic Signature process works in the following way:
