GxPlex

Verification: frozen · Subject (as stated): no self-stated subject

13 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 13 (active — select again to clear) artificial intelligence 3 software 3 medical devices 1 security 1 computerised systems 3 manufacturing 1 data integrity 1
+3 more quality management 1 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.

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

Showing 13 of 86 instruments. Clear all filters

Verification: frozen · Subject (as stated): no self-stated subject — 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
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 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)
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)
PMDA AI Pharmaceuticals and Medical Devices Agency Japan not yet verified frozen listing only link (opens in new tab)
prEN 18282 CEN/CENELEC JTC 21 EU not yet verified frozen paywalled — progression tracked 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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