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21 CFR Part 11 - Zymergi Support
CFR Part 11 defines the criteria under which the FDA will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures executed on paper.
The goal of 21 CFR Part 11 is to permit the widest possible use of electronic technology so long as that use is compatible with the FDA’s responsibility to promote and protect public health.
1 PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
1.1 Subpart A—General Provisions
1.1.1 § 11.1 Scope.
1.1.2 § 11.2 Implementation
1.1.3 § 11.3 Definitions
1.2 Subpart B—Electronic Records
1.2.1 § 11.10 Controls for closed systems
1.2.2 § 11.30 Controls for open systems
1.2.3 § 11.50 Signature manifestations
1.2.4 § 11.70 Signature/record linking.
1.3 Subpart C—Electronic Signatures
1.3.1 § 11.100 General requirements.
1.3.2 § 11.200 Electronic signature components and controls
1.3.3 § 11.300 Controls for identification codes/passwords
(2) The document or parts of a document to be submitted have been identified in public docket No. 92S–0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.
(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronicsignature, the organization shall verify the identity of the individual.
Dated: March 11, 1997.
FR Doc. 97–6833 Filed 3–20–97; 8:45 am
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