GxPlex

Status: final · Subject (as stated): software

4 of 86 tracked instruments.

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

Status frozen 4 draft 1 final 4 (active — select again to clear)

Ordered by the lifecycle the values themselves name.

Subject (as stated) no self-stated subject 6 artificial intelligence 6 software 4 (active — select again to clear) security 2 computerised systems 1 manufacturing 3 risk management 2 data integrity 2
+11 more quality management 1 trustworthiness 1 validation 2 clinical 2 cybersecurity 1 electronic records 1 electronic signatures 1 machine learning 1 computer software 1 data quality 1 governance 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 4 of 86 instruments. Clear all filters

Status: final · Subject (as stated): software — 4 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
FDA CSA US Food and Drug Administration US final verified 2026-07-30 — link (opens in new tab) · retrieved
FDA PCCP US Food and Drug Administration US final verified 2026-07-28 — link (opens in new tab) · retrieved
FDA software validation US Food and Drug Administration US final tool-read 2026-07-31 — link (opens in new tab) · retrieved
MHRA AI Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 — link (opens in new tab) · retrieved

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