Under 21 CFR Part 11, which combination of controls makes an electronic signature legally equivalent to a handwritten signature for FDA-regulated records?
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A
Username and password alone, without additional audit trail
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B
A printed name and date applied to a PDF document
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C
At least two distinct identification components (e.g., ID code + password) with a binding statement linking the signature to the record
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D
A digital certificate issued by any third-party authority