GxPlex

Status: final

31 of 86 tracked instruments.

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

Jurisdiction International 17 EU 3 US 8 UK 2 China 1

Ordered by count, then alphabetically.

Class (as stated) no self-stated class 19 consensus standard 10 authority guidance 2

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Showing 31 of 86 instruments. Clear all filters

Status: final — 31 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 E2363 ASTM International International final verified 2026-07-29 link (opens in new tab) · retrieved
ASTM E2500 ASTM International International final verified 2026-07-29 link (opens in new tab) · retrieved
EMA AI reflection paper European Medicines Agency EU final check unrecorded 2026-07-28 link (opens in new tab) · retrieved
EMA CT computerised systems European Medicines Agency EU final verified 2026-08-01 link (opens in new tab) · retrieved
EMA work programme European Medicines Agency EU final verified 2026-07-28 link (opens in new tab) · retrieved
FDA CSA US Food and Drug Administration US final verified 2026-07-30 link (opens in new tab) · retrieved
FDA data integrity US Food and Drug Administration US final verified 2026-07-28 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 PCCP US Food and Drug Administration US final verified 2026-07-28 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
ICH E6(R3) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q12 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q13 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q14 International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
ICH Q2(R2) International Council for Harmonisation International final verified 2026-07-30 link (opens in new tab) · retrieved
ICH Q9(R1) International Council for Harmonisation International final verified 2026-07-29 link (opens in new tab) · retrieved
IEEE 7000 Institute of Electrical and Electronics Engineers International final verified 2026-07-30 link (opens in new tab) · retrieved
ISO/IEC 22989 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 23894 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 24028 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 38507 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42001 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42005 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 5259 ISO/IEC International final verified 2026-07-29 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
MHRA data integrity Medicines and Healthcare products Regulatory Agency UK final tool-read 2026-07-31 link (opens in new tab) · retrieved
NIST CSF 2.0 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
NIST SP 800-82 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
NMPA National Medical Products Administration China final verified 2026-07-28 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

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