GxPlex

Jurisdiction: US · Subject (as stated): manufacturing

2 of 86 tracked instruments.

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

Jurisdiction International 3 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 (active — select again to clear) 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): manufacturing — 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 211 US Food and Drug Administration US in force verified 2026-08-01 — link (opens in new tab) · retrieved
FDA process analytical framework US Food and Drug Administration US final tool-read 2026-07-31 — link (opens in new tab) · retrieved

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