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Jurisdiction: US · Subject (as stated): electronic records

2 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Jurisdiction US 2 (active — select again to clear)

Ordered by count, then alphabetically.

Subject (as stated) no self-stated subject 4 artificial intelligence 2 software 4 medical devices 2 security 3 manufacturing 2 data integrity 1 quality management 1
+6 more validation 1 cybersecurity 2 electronic records 2 electronic signatures 2 good manufacturing practice 1 computer software 1

Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.

Two facets compose at a time; the other groups return when one is cleared.

Showing 2 of 86 instruments. Clear all filters

Jurisdiction: US · Subject (as stated): electronic records — 2 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
21 CFR Part 11 US Food and Drug Administration US in force verified 2026-08-01 — link (opens in new tab) · retrieved
FDA Part 11 scope US Food and Drug Administration US final tool-read 2026-07-31 — link (opens in new tab) · retrieved

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