GxPlex

Status: frozen

36 of 86 tracked instruments.

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

Subject (as stated) no self-stated subject 16 artificial intelligence 3 software 4 medical devices 3 security 4 computerised systems 3 manufacturing 1 risk management 1
+5 more data integrity 1 information security 3 quality management 2 trustworthiness 2 good manufacturing practice 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 17 consensus standard 14 authority guidance 5

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 36 of 86 instruments. Clear all filters

Status: frozen — 36 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
ANVISA Agência Nacional de Vigilância Sanitária Brazil not yet verified frozen listing only link (opens in new tab)
ASTM E2537 ASTM International International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
CEN/CLC JTC 21 CEN/CENELEC EU not yet verified frozen not a document link (opens in new tab)
DI revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only link (opens in new tab)
FDA AI device list US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA ETP US Food and Drug Administration US not yet verified frozen not a document link (opens in new tab)
FDA guidance agenda US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
GAMP 5 2nd Ed ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
GAMP AI Guide ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
IEC 62304 ISO/IEC International final tool-read paywalled — progression tracked 2026-07-31 link (opens in new tab) · retrieved
IEC 62443 IEC / ISA International not yet verified frozen paywalled — progression tracked link (opens in new tab)
IMDRF AI/ML WG International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
IMDRF SaMD International Medical Device Regulators Forum International not yet verified frozen blocks automated requests link (opens in new tab)
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
ISO/IEC 27001 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27002 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27017 ISO/IEC International withdrawn verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27018 ISO/IEC International withdrawn verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC SC 42 ISO/IEC International not yet verified frozen not a document 2026-07-31 link (opens in new tab) · retrieved
ISPE Pharma 4.0 International Society for Pharmaceutical Engineering International not yet verified frozen not a document link (opens in new tab)
MHRA AI Airlock Medicines and Healthcare products Regulatory Agency UK not yet verified frozen not a document 2026-07-31 link (opens in new tab) · retrieved
NIST agent standards US National Institute of Standards and Technology US not yet verified frozen not a document link (opens in new tab)
NIST AI RMF Playbook US National Institute of Standards and Technology US not yet verified frozen register states no status link (opens in new tab)
PIC/S Annex 11 Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only link (opens in new tab)
PIC/S GMP Guide Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen paywalled — progression tracked link (opens in new tab)
PIC/S PI 041 Pharmaceutical Inspection Co-operation Scheme International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
PMDA AI Pharmaceuticals and Medical Devices Agency Japan not yet verified frozen listing only link (opens in new tab)
prEN 18229-1 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18229-2 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18281 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
prEN 18282 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked link (opens in new tab)
Swissmedic Swissmedic Switzerland not yet verified frozen listing only link (opens in new tab)
TGA SaMD Therapeutic Goods Administration Australia not yet verified frozen blocks automated requests link (opens in new tab)
WHO computerised systems World Health Organization International not yet verified frozen listing only link (opens in new tab)
WHO data management World Health Organization International not yet verified frozen listing only link (opens in new tab)

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