GxPlex

Verification: tool-read

13 of 86 tracked instruments. read from the source by tooling, because the publisher prints no status a machine can read

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

Status frozen 4 final 5 in-force 4

Ordered by the lifecycle the values themselves name.

Jurisdiction International 5 EU 4 US 3 UK 1

Ordered by count, then alphabetically.

Subject (as stated) no self-stated subject 4 artificial intelligence 1 software 2 medical devices 2 manufacturing 1 risk management 1 data integrity 1 quality management 1
+3 more validation 2 electronic records 1 electronic signatures 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.

Class (as stated) no self-stated class 5 consensus standard 4 authority guidance 2 legal act 2

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

Two facets compose at a time.

Showing 13 of 86 instruments. Clear all filters

Verification: tool-read — 13 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
ASTM E2537 ASTM International International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
EU Cyber Resilience Act European Parliament and Council EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU GMP Annex 15 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU GMP Chapter 4 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU NIS2 Directive European Parliament and Council EU in force tool-read 2026-07-31 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
FDA process analytical framework US Food and Drug Administration US final tool-read 2026-07-31 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
IEC 62304 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
ISO 13485 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
ISO 14971 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
MHRA data integrity Medicines and Healthcare products Regulatory Agency UK final tool-read 2026-07-31 link (opens in new tab) · retrieved
WHO AI health World Health Organization International final tool-read 2026-07-30 link (opens in new tab) · retrieved

Last updated: