What's New
OCTOBER 2018 EDITION
About Title 21 Part 11 Android App
21 CFR FDA Part 11 - Electronic Records; Electronic Signatures
Data is current as of October 1, 2018
Contents:
Subpart A - GENERAL PROVISIONS
§11.1 Scope.
§11.2 Implementation.
§11.3 Definitions.
Subpart B - ELECTRONIC RECORDS
§11.10 Controls for closed systems.
§11.30 Controls for open systems.
§11.50 Signature manifestations.
§11.70 Signature/record linking.
Subpart C - ELECTRONIC SIGNATURES
§11.100 General requirements.
§11.200 Electronic signature components and controls.
§11.300 Controls for identification codes/passwords.
Other Information:
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