GxPlex

AI, cybersecurity, computerised systems and data integrity under GxP — a dated record of what regulators published

86 instruments, observed daily and hashed where the text is public, so a change can be shown rather than asserted. It does not interpret — no recommendations, and no assessment of what any document requires of anyone.

What this record can answer

Five questions, each linked to the page that answers it. The figures are counted from the record at build time.

  1. What did a document say on a particular date? EMA AI reflection paper, as retrieved on 29 July 2026 18 retained snapshot(s)
  2. What has changed, and when? Every recorded change, dated also as a feed — changes.xml
  3. Which documents use a term, in their own words? “audit trail”, quoted from 3 documents 9 term(s), each quotation cited to its source
  4. Which documents share a stated subject? Subject: security — 7 documents matched by the publishers' own words: "information security" and "cybersecurity" both contain "security", and no synonym list is applied
  5. What dates has a publisher stated? Next stated date: 16 dated entries, each with its source
What these states mean
verified
checked against the primary source by a person
tool-read
read from the source by tooling, because the publisher prints no status a machine can read
check unrecorded
a status is recorded and no check is written against it
checked — no status stated
a person checked the publisher's own surfaces and none states a status
awaiting
not yet checked
frozen
no public document exists to verify — each entry states which
Status unknown 6 frozen 36 draft 3 final 31 in-force 10

Ordered by the lifecycle the values themselves name.

Class (as stated) no self-stated class 43 consensus standard 24 authority guidance 12 legal act 7

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.

All 86 tracked instruments from 21 authorities, most recently changed first — 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
21 CFR Part 11 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
21 CFR Part 211 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
Annex 11 concept paper European Medicines Agency EU not yet verified awaiting link (opens in new tab)
Annex 15 revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified awaiting link (opens in new tab)
ANVISA Agência Nacional de Vigilância Sanitária Brazil not yet verified frozen listing only link (opens in new tab)
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
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)
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
EU AI Act European Parliament and Council EU in force verified 2026-07-28 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 11 European Commission EU in force verified 2026-07-30 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 Annex 22 European Commission EU not yet verified awaiting link (opens in new tab)
EU GMP Chapter 4 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU IVDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU MDR European Parliament and Council EU in force verified 2026-07-28 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 AI device list US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
FDA AI guidance US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 link (opens in new tab) · retrieved
FDA CDRH AI/ML US Food and Drug Administration US draft — recorded as draft against the primary source verified 2026-07-30 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 device cybersecurity US Food and Drug Administration US not yet verified awaiting 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)
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
FDA/EMA AI principles US Food and Drug Administration and European Medicines Agency International not yet verified awaiting 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)
Health Canada ML Health Canada Canada draft — under consultation verified 2026-07-28 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
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)
IEEE 7000 Institute of Electrical and Electronics Engineers International final verified 2026-07-30 link (opens in new tab) · retrieved
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 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 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 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
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 Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 link (opens in new tab) · retrieved
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
MHRA data integrity Medicines and Healthcare products Regulatory Agency UK final tool-read 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 US National Institute of Standards and Technology International not yet verified checked — no status stated 2026-08-01 link (opens in new tab) · retrieved
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)
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
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 AI health World Health Organization International final tool-read 2026-07-30 link (opens in new tab) · retrieved
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)

Recent activity

Every recorded change

The archive

Instruments tracked
86
Observations recorded
621
Instrument-days observed
104
Days of continuous observation
7 since 28 July 2026
Revisions detected
0 detection requires a prior hash; observation began 28 July 2026
Silent revisions
0 a change with no version or date declared alongside it

Continuous observation began on . A revision is detected by comparing a document against a hash recorded on an earlier day, so detections become possible from the second day of observation onward. A regulator that revised a document before that date left no trace here, and this site does not claim otherwise.

Every tracked document is fetched, normalised and hashed daily. The hash is recorded whether or not anything changed — "unchanged for 7 days" is only a fact if every one of those days was observed. A silent revision is a document whose content changed with no version or date declared alongside it.

Detected revisions · Findings, each with its method · Which sources are machine-readable · Snapshots and hashes · How this is done

Current status of tracked instruments

A view of the archive, not the product. Status is recorded only after a person has checked it against the primary source.

5 of 86 statuses are awaiting verification. A further 36 are frozen: no public document exists to verify them against, and each states which. The verification strip shows 27 frozen rather than 36: 9 frozen entries carry a known status and are counted by how they were checked. Being frozen and having a status are independent facts. Observation runs for all of them regardless — observation and verification are independent.

Machine-readable

/api/v1/observations.json · /api/v1/revisions.json · /api/v1/findings.json · /api/v1/crawlability.json · /api/v1/instruments.json · RSS

Last updated: