What is an electronic signature 21 CFR Part 11?
The term “Part 11” applies to records in electronic form that are created, modified, maintained, archived, retrieved, transmitted or submitted, under any records requirements set forth by the FDA regulations/predicate rules.
Which of the following statements are the requirements of 21 CFR Part 11?
A: 21 CFR 11 requires that closed computer systems must have a collection of technological and procedural controls to protect data within the system. Open computer systems must also include controls to ensure that all records are authentic, incorruptible, and (where applicable) confidential.
What level is the part of 21 CFR that deals with electronic records and electronic signatures?
21 CFR Part 11
21 CFR Part 11; Electronic Records; Electronic Signatures, Validation.
What makes a signature Part 11 compliant?
A Part 11 compliant system must be able to assign unique electronic signatures to each user, which must be certified in writing by the owner of the signature to be legally equivalent to a binding signature.
What is electronic records and electronic signatures?
(7) “Electronic record” means a record created, generated, sent, communicated, received, or stored by electronic means. (8) “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.
What is Part 11 compliant signature?
Part 11 describes the circumstances for when the FDA considers electronic signatures to be trustworthy, reliable, and equivalent to handwritten signatures executed on paper. T Part 11 subpart A, general provisions, lists the types of records to which the provisions of electronic signatures apply.
Does 21 CFR Part 11 apply to me?
Does 21 CFR Part 11 apply to me, then? Almost certainly. Any developer releasing a product in the US who thinks they won’t be subject to the regulation because their ‘master copies’ of documentation are all in paper form are probably mistaken.
What are the predicate rules for Part 11?
The predicate rules mandate what records must be maintained; the content of records; whether signatures are required; how long records must be maintained, etc. If there is no FDA requirement that a particular record be created or retained, then 21 CFR Part 11 most likely does not apply to the record.