Applicability
Electronic records and electronic signatures within the scope defined by Part 11 and the applicable predicate rules.
What Changed
This record links to the current official text; it does not claim a new amendment.
What Did Not Change
Applicability remains record- and use-specific. The predicate rule, electronic reliance, and signature use must be understood.
Practical Impact
Maintain decisions for record integrity, access, audit trails, signatures, retention, accurate copies, and operational controls.
Actions to Consider
Identify the required record first, then assess the configured electronic workflow and applicable controls.
Primary Source
Revision history
Version 1.2 · 12 September 2026: Terminology and source fields standardized for Version 32.