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

Fetched 132 of 132 tracked entries on 2026-09-18 · 18 withheld by the publisher’s terms · 6 of 152 not retrieved · 4 digests moved, each a candidate · candidates: 0 offered as a change to a document, 1 as a change to a page about one, 9 waiting on a later reading, 59 withheld with a reason · 0 text changes confirmed by a person · 16 of 107 status values carry no verification act (derived at build 976ab06a8315 · 2026-09-18 UTC)

Guidance changes without notice. This is the dated record of what it says. What each page said on the day it was read, and the command that verifies it. What that means, and what is not tracked

12 digests moved in the seven days to 2026-09-18 . 12 candidates are staged for days in that window: 0 offered as a change to a document, 0 as a change to a page about one, 5 waiting on a later reading, 7 withheld — a digest moving is not a document changing
0 official signals across 2 declared source(s), none of which has been read: every zero below it is an unasked question rather than a source that listed nothing
13 work items — change candidates of 69 recorded candidate(s)
16 work items — status values of 107 row(s) on the verification axis
0 upcoming dates in the horizon ending 2026-12-17; 3 dated event(s) sit beyond it, the nearest on 2026-12-31

Changed this week

0 of 132 tracked entries carry a status change recorded in the seven days to 2026-09-18; 132 carry none. A recorded absence is not an observed one — this counts what the log holds, and the bars on the board carry which days each entry was checked.

All changes · the board

Next 90 days

No date in the next 90 days is recorded from a publisher’s own page.

The calendar

What this record can vouch for

132 tracked — entries this record holds
132 monitored — of those, with an observation series

55 verified — a person confirmed the status against the source
16 awaiting — no person has confirmed this status yet
1 tool-read — read from the source by tooling, not by a person
1 no status stated — a person read the source and it states no status
34 source-limited — paywalled, listing-only, or automated access refused
25 register-only — tracked as a register entry; no status is promised

What each of these means · these 6 states divide all 132

Change candidates, by stage

A candidate is a pair of digests that differ. It is not a revision until something establishes that the bytes are a revision of the document the row names.

69 detected
56 of 69 resolved by rule
- 21 excluded chrome
- 18 oscillation
- 15 attribute residue
- 1 declared listing
- 1 recorded as a change of the witness
13 of 69 with no verdict recorded
0 of 69 confirmed by analysis
0 of 69 confirmed by a person

Rule classes recorded here and not named in the order that asked for this block: recorded as a change of the witness, declared listing.

Named in that order with no member in this store: wrong referent, witness change.

Detected candidates

Differences between observations

The diff collection holds 0 entries, and this record holds 0 confirmed revisions. Both are stores nothing has been promoted into: the block beside this one counts what detection has staged, and no verdict has moved any of it here.

Changes — status changes and confirmed revisions to tracked documents

Every recorded date

17 dates are on this record’s calendar; 0 of them fall in the Next 90 days block above.

Regulatory calendar

Comparing two observations

The archive holds 18 records, each fixing one document at one moment, and the observation series is published whole.

Source archive · the observation series

What the marks mean

Last 90 days — one mark per day

the document changed
checked, unchanged
could not be retrieved — nothing hashed
no check ran that day
before this document was tracked

Status — what the publisher published

in force
final
draft
proposed
superseded
withdrawn
unknown

Verification — whether a person checked our reading

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
awaiting — not yet checked
checked — no status stated — a person checked the publisher's own surfaces and none states a status
check unrecorded — a status is recorded and no check is written against it
not re-checked — no status recorded; each row states its reason
a register — observed daily; no person-verification is promised

How long this record has watched

observed for under a month — too short to read an absence of change from
observed for one to three months
observed for three months to a year
observed for more than a year

The board shows each entry’s exact span in days; the bands above group those spans. Counted from this record’s first observation of that entry to today, not from the day the archive began: an entry admitted in August was not unobserved in July, it was not yet tracked.

A lens narrows this board in the browser and is carried in the address after the #. With scripting off no lens is applied and the board below shows all 132 tracked entries.

All 107 core · 25 register from 31 authorities, most recently changed first — no row carries a change date yet, so rows are alphabetical; they order by change date as soon as one does.
Regulation	Publisher	Status	Verification	Last 90 days	Last checked	Changed on
21 CFR Part 11 US	US Food and Drug Administration	in force	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 11 of 151 digest comparisons differ · verification: verified
21 CFR Part 211 US	US Food and Drug Administration	in force	verified		2026-09-18 watched 50 days	no confirmed change 49 of the 50 days since 2026-07-31 hold a digest · 9 of 107 digest comparisons differ · verification: verified
21 CFR Part 820 (QMSR) US	US Food and Drug Administration	unknown	awaiting		2026-09-18 watched 46 days	no confirmed change 45 of the 46 days since 2026-08-04 hold a digest · 9 of 92 digest comparisons differ · verification: awaiting
Annex 11 concept paper EU	European Medicines Agency	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 103 digest comparisons differs · verification: awaiting
Annex 15 revision concept paper International	European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 104 digest comparisons differs · verification: awaiting
ANVISA Brazil	Agência Nacional de Vigilância Sanitária	unknown	not re-checked listing only		2026-08-17 watched 33 days	— no digest recorded in 1 observations
ASTM E2363 International	ASTM International	final	verified		2026-09-18 watched 52 days	no confirmed change 52 consecutive observation days since 2026-07-29 · 1 of 136 digest comparisons differs · verification: verified
ASTM E2500 International	ASTM International	final	verified		2026-09-18 watched 52 days	no confirmed change 52 consecutive observation days since 2026-07-29 · 1 of 136 digest comparisons differs · verification: verified
ASTM E2537 International	ASTM International	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 108 digest comparisons differs · verification: not re-checked
CEN/CLC JTC 21 EU	CEN/CENELEC	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 49 of the 53 days since 2026-07-28 hold a digest · verification: not re-checked
CISA CPG 2.0 register US	Cybersecurity and Infrastructure Security Agency	unknown	a register		2026-09-18 watched 38 days	no confirmed change 38 consecutive observation days since 2026-08-12 · 1 of 60 digest comparisons differs · verification: a register
DI revision concept paper International	European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme	unknown	not re-checked listing only		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 107 digest comparisons differs · verification: not re-checked
EMA AI reflection paper EU	European Medicines Agency	final	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 26 of 144 digest comparisons differ · verification: verified
EMA CT computerised systems EU	European Medicines Agency	final	verified		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 108 digest comparisons differs · verification: verified
EMA data quality framework EU	European Medicines Agency	final	verified		2026-09-18 watched 46 days	no confirmed change 45 of the 46 days since 2026-08-04 hold a digest · 1 of 91 digest comparisons differs · verification: verified
EMA work programme EU	European Medicines Agency	final	verified		2026-09-18 watched 53 days	no confirmed change 51 of the 53 days since 2026-07-28 hold a digest · 2 of 111 digest comparisons differ · verification: verified
EU AI Act EU	European Parliament and Council	in force	verified		2026-09-18 watched 53 days	no confirmed change 26 of the 53 days since 2026-07-28 hold a digest · 1 of 76 digest comparisons differs · verification: verified
EU Cyber Resilience Act EU	European Parliament and Council	in force	verified		2026-09-18 watched 50 days	no confirmed change 23 of the 50 days since 2026-07-31 hold a digest · verification: verified
EU Cybersecurity Act EU	European Parliament and Council	in force	verified		2026-09-18 watched 46 days	no confirmed change 19 of the 46 days since 2026-08-04 hold a digest · verification: verified
EU GMP Annex 1 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 10 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 11 EU	European Commission	in force	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
EU GMP Annex 11 (draft) EU	European Commission	unknown	awaiting		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · 1 of 93 digest comparisons differs · verification: awaiting
EU GMP Annex 12 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 13 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 14 register EU	European Commission	in force	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 15 EU	European Commission	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 109 digest comparisons differs · verification: awaiting
EU GMP Annex 16 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 17 register EU	European Commission	in force	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 19 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 2 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 21 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 22 EU	European Commission	unknown	awaiting		2026-09-18 watched 53 days	no confirmed change 52 of the 53 days since 2026-07-28 hold a digest · 2 of 152 digest comparisons differ · verification: awaiting
EU GMP Annex 3 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 6 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 7 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 34 of the 35 days since 2026-08-15 hold a digest · 1 of 52 digest comparisons differs · verification: a register
EU GMP Annex 8 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 35 consecutive observation days since 2026-08-15 · 1 of 53 digest comparisons differs · verification: a register
EU GMP Annex 9 register EU	European Commission	unknown	a register		2026-09-18 watched 35 days	no confirmed change 34 of the 35 days since 2026-08-15 hold a digest · 1 of 52 digest comparisons differs · verification: a register
EU GMP Chapter 1 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 2 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 3 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 4 EU	European Commission	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 109 digest comparisons differs · verification: awaiting
EU GMP Chapter 4 (draft) EU	European Commission	unknown	awaiting		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · 1 of 93 digest comparisons differs · verification: awaiting
EU GMP Chapter 5 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 6 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 7 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 8 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU GMP Chapter 9 register EU	European Commission	unknown	a register		2026-09-18 watched 39 days	no confirmed change 39 consecutive observation days since 2026-08-11 · 1 of 67 digest comparisons differs · verification: a register
EU IVDR EU	European Parliament and Council	in force	verified		2026-09-18 watched 53 days	no confirmed change 26 of the 53 days since 2026-07-28 hold a digest · verification: verified
EU Machinery Regulation EU	European Parliament and Council	in force	verified		2026-09-18 watched 46 days	no confirmed change 19 of the 46 days since 2026-08-04 hold a digest · 1 of 42 digest comparisons differs · verification: verified
EU MDR EU	European Parliament and Council	in force	verified		2026-09-18 watched 53 days	no confirmed change 26 of the 53 days since 2026-07-28 hold a digest · 1 of 76 digest comparisons differs · verification: verified
EU NIS2 Directive EU	European Parliament and Council	in force	verified		2026-09-18 watched 50 days	no confirmed change 23 of the 50 days since 2026-07-31 hold a digest · verification: verified
FDA AI device list US	US Food and Drug Administration	unknown	not re-checked register states no status		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 1 of 147 digest comparisons differs · verification: not re-checked
FDA AI guidance US	US Food and Drug Administration	draft — recorded as draft against the primary source	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
FDA CDRH AI/ML US	US Food and Drug Administration	draft — recorded as draft against the primary source	verified		2026-09-18 watched 51 days	no confirmed change 51 consecutive observation days since 2026-07-30 · verification: verified
FDA clinical decision support US	US Food and Drug Administration	final	verified		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · verification: verified
FDA CSA US	US Food and Drug Administration	final	verified		2026-09-18 watched 51 days	no confirmed change 51 consecutive observation days since 2026-07-30 · verification: verified
FDA data integrity US	US Food and Drug Administration	final	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: verified
FDA device cybersecurity US	US Food and Drug Administration	superseded	tool-read status recorded as tool-read · document text not yet hashed by this record	witness only — this record has not hashed this document	—	— this record has not hashed this document
FDA device cybersecurity (2026) US	US Food and Drug Administration	final	verified		2026-09-18 watched 42 days	no confirmed change 42 consecutive observation days since 2026-08-08 · 1 of 85 digest comparisons differs · verification: verified
FDA electronic systems (clinical) US	US Food and Drug Administration	final	verified		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · 1 of 93 digest comparisons differs · verification: verified
FDA ETP US	US Food and Drug Administration	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
FDA GMLP guiding principles US	US Food and Drug Administration	unknown	awaiting		2026-09-18 watched 28 days	no confirmed change 28 consecutive observation days since 2026-08-22 · verification: awaiting
FDA guidance agenda US	US Food and Drug Administration	unknown	not re-checked register states no status		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: not re-checked
FDA Part 11 scope US	US Food and Drug Administration	final	verified		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: verified
FDA PCCP US	US Food and Drug Administration	final	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: verified
FDA postmarket cybersecurity US	US Food and Drug Administration	final	verified		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · verification: verified
FDA process analytical framework US	US Food and Drug Administration	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: awaiting
FDA software validation US	US Food and Drug Administration	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: awaiting
FDA/EMA AI principles International	US Food and Drug Administration and European Medicines Agency	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 1 of 108 digest comparisons differs · verification: awaiting
GAMP 5 2nd Ed International	ISPE	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 4 of 151 digest comparisons differ · verification: not re-checked
GAMP AI Guide International	ISPE	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 6 of 152 digest comparisons differ · verification: not re-checked
Health Canada ML Canada	Health Canada	draft — under consultation	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 1 of 145 digest comparisons differs · verification: verified
ICH E6(R3) International	International Council for Harmonisation	final	verified		2026-09-02 watched 50 days	— no digest recorded in 29 observations
ICH Q12 International	International Council for Harmonisation	final	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
ICH Q13 International	International Council for Harmonisation	final	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
ICH Q14 International	International Council for Harmonisation	final	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
ICH Q2(R2) International	International Council for Harmonisation	final	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
ICH Q9(R1) International	International Council for Harmonisation	final	verified		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: verified
IEC 62304 International	ISO/IEC	final	verified		2026-09-18 watched 50 days	no confirmed change 24 of the 50 days since 2026-07-31 hold a digest · 2 of 38 digest comparisons differ · verification: verified
IEC 62443 International	IEC / ISA	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: not re-checked
IEC 81001-5-1 International	IEC	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 42 days	no confirmed change 42 consecutive observation days since 2026-08-08 · 2 of 85 digest comparisons differ · verification: not re-checked
IEEE 7000 International	Institute of Electrical and Electronics Engineers	final	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: verified
IMDRF AI/ML WG International	International Medical Device Regulators Forum	unknown	not re-checked blocks automated requests		2026-09-18 watched 53 days	— no digest recorded in 145 observations
IMDRF SaMD International	International Medical Device Regulators Forum	unknown	not re-checked blocks automated requests		2026-09-18 watched 53 days	— no digest recorded in 145 observations
ISO 13485 International	ISO/IEC	final	verified		2026-09-18 watched 50 days	no confirmed change 22 of the 50 days since 2026-07-31 hold a digest · verification: verified
ISO 14971 International	ISO/IEC	final	verified		2026-09-18 watched 50 days	no confirmed change 18 of the 50 days since 2026-07-31 hold a digest · 2 of 40 digest comparisons differ · verification: verified
ISO 81001-1 International	ISO	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 42 days	— no digest recorded in 40 observations
ISO/IEC 22989 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 26 of the 53 days since 2026-07-28 hold a digest · 1 of 55 digest comparisons differs · verification: verified
ISO/IEC 23894 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 23 of the 53 days since 2026-07-28 hold a digest · verification: verified
ISO/IEC 24028 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 23 of the 53 days since 2026-07-28 hold a digest · 23 of 59 digest comparisons differ · verification: verified
ISO/IEC 27001 International	ISO/IEC	final	verified		2026-09-18 watched 50 days	no confirmed change 29 of the 50 days since 2026-07-31 hold a digest · verification: verified
ISO/IEC 27002 International	ISO/IEC	final	verified		2026-09-18 watched 50 days	no confirmed change 24 of the 50 days since 2026-07-31 hold a digest · verification: verified
ISO/IEC 27017 International	ISO/IEC	withdrawn	verified		2026-09-18 watched 50 days	no confirmed change 20 of the 50 days since 2026-07-31 hold a digest · verification: verified
ISO/IEC 27017:2026 International	ISO/IEC	final	verified		2026-09-18 watched 42 days	no confirmed change 14 of the 42 days since 2026-08-08 hold a digest · 4 of 21 digest comparisons differ · verification: verified
ISO/IEC 27018 International	ISO/IEC	withdrawn	verified		2026-09-18 watched 50 days	no confirmed change 24 of the 50 days since 2026-07-31 hold a digest · verification: verified
ISO/IEC 27018:2025 International	ISO/IEC	final	verified		2026-09-18 watched 42 days	no confirmed change 14 of the 42 days since 2026-08-08 hold a digest · verification: verified
ISO/IEC 38507 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 22 of the 53 days since 2026-07-28 hold a digest · 25 of 58 digest comparisons differ · verification: verified
ISO/IEC 42001 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 20 of the 53 days since 2026-07-28 hold a digest · verification: verified
ISO/IEC 42005 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 28 of the 53 days since 2026-07-28 hold a digest · 26 of 69 digest comparisons differ · verification: verified
ISO/IEC 5259 International	ISO/IEC	final	verified		2026-09-18 watched 53 days	no confirmed change 24 of the 53 days since 2026-07-28 hold a digest · 22 of 60 digest comparisons differ · verification: verified
ISO/IEC SC 42 International	ISO/IEC	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 29 of the 53 days since 2026-07-28 hold a digest · 24 of 69 digest comparisons differ · verification: not re-checked
ISPE GAMP RDI International	International Society for Pharmaceutical Engineering	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · 4 of 93 digest comparisons differ · verification: not re-checked
ISPE Pharma 4.0 International	International Society for Pharmaceutical Engineering	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
MHRA AI UK	Medicines and Healthcare products Regulatory Agency	final	verified		2026-09-18 watched 51 days	no confirmed change 51 consecutive observation days since 2026-07-30 · 8 of 123 digest comparisons differ · verification: verified
MHRA AI Airlock UK	Medicines and Healthcare products Regulatory Agency	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 51 of the 53 days since 2026-07-28 hold a digest · 8 of 123 digest comparisons differ · verification: not re-checked
MHRA data integrity UK	Medicines and Healthcare products Regulatory Agency	unknown	awaiting		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 9 of 109 digest comparisons differ · verification: awaiting
NIST agent standards US	US National Institute of Standards and Technology	unknown	not re-checked not a document		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 7 of 145 digest comparisons differ · verification: not re-checked
NIST AI 600-1 US	US National Institute of Standards and Technology	unknown	awaiting		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · 1 of 93 digest comparisons differs · verification: awaiting
NIST AI RMF International	US National Institute of Standards and Technology	unknown	checked — no status stated		2026-09-18 watched 12 days	no confirmed change 3 of the 12 days since 2026-09-07 hold a digest · verification: checked — no status stated
NIST AI RMF Playbook US	US National Institute of Standards and Technology	unknown	not re-checked register states no status		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 1 of 145 digest comparisons differs · verification: not re-checked
NIST CSF 2.0 US	US National Institute of Standards and Technology	final	verified		2026-07-31 watched 50 days	no confirmed change 1 of the 50 days since 2026-07-31 holds a digest · verification: verified
NIST SP 800-82 US	US National Institute of Standards and Technology	final	verified		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: verified
NISTIR 8183 register US	National Institute of Standards and Technology	unknown	a register		2026-09-18 watched 38 days	no confirmed change 38 consecutive observation days since 2026-08-12 · 1 of 60 digest comparisons differs · verification: a register
NMPA portal China	National Medical Products Administration	unknown	not re-checked listing only		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 2 of 145 digest comparisons differ · verification: not re-checked
PDA TR 80 International	Parenteral Drug Association	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 42 days	no confirmed change 22 of the 42 days since 2026-08-08 hold a digest · verification: not re-checked
PIC/S Annex 11 International	Pharmaceutical Inspection Co-operation Scheme	unknown	not re-checked listing only		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · verification: not re-checked
PIC/S GMP Guide International	Pharmaceutical Inspection Co-operation Scheme	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 1 of 151 digest comparisons differs · verification: not re-checked
PIC/S PI 011 International	Pharmaceutical Inspection Co-operation Scheme	unknown	not re-checked listing only		2026-09-18 watched 46 days	no confirmed change 46 consecutive observation days since 2026-08-04 · verification: not re-checked
PIC/S PI 041 International	Pharmaceutical Inspection Co-operation Scheme	final	verified		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 1 of 145 digest comparisons differs · verification: verified
PMDA AI Japan	Pharmaceuticals and Medical Devices Agency	unknown	not re-checked listing only		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · 35 of 144 digest comparisons differ · verification: not re-checked
prEN 18229-1 EU	CEN/CENELEC JTC 21	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
prEN 18229-2 EU	CEN/CENELEC JTC 21	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
prEN 18281 EU	CEN/CENELEC JTC 21	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
prEN 18282 EU	CEN/CENELEC JTC 21	unknown	not re-checked paywalled — progression tracked		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
Regulation (EU) 2026/1744 EU	European Parliament and Council	in force	verified		2026-09-18 watched 46 days	no confirmed change 19 of the 46 days since 2026-08-04 hold a digest · verification: verified
Swissmedic Switzerland	Swissmedic	unknown	not re-checked listing only		2026-09-18 watched 53 days	no confirmed change 53 consecutive observation days since 2026-07-28 · verification: not re-checked
TGA SaMD Australia	Therapeutic Goods Administration	unknown	not re-checked blocks automated requests		2026-09-18 watched 53 days	— no digest recorded in 145 observations
WHO AI health International	World Health Organization	unknown	awaiting		2026-09-18 watched 53 days	no confirmed change 52 of the 53 days since 2026-07-28 hold a digest · 1 of 143 digest comparisons differs · verification: awaiting
WHO computerised systems International	World Health Organization	unknown	not re-checked listing only		2026-09-18 watched 53 days	no confirmed change 50 of the 53 days since 2026-07-28 hold a digest · 1 of 111 digest comparisons differs · verification: not re-checked
WHO data integrity guideline International	World Health Organization	unknown	awaiting		2026-09-18 watched 42 days	no confirmed change 41 of the 42 days since 2026-08-08 hold a digest · verification: awaiting
WHO data management International	World Health Organization	unknown	not re-checked listing only		2026-09-18 watched 50 days	no confirmed change 50 consecutive observation days since 2026-07-31 · 45 of 108 digest comparisons differ · verification: not re-checked

What this record is, and what it refuses

This record holds 132 tracked entries. An observation records the day the publisher’s own page was read, the URL the request answered at, and, where the text is public, a SHA-256 digest of the text as it was read that day. The series begins on 28 July 2026.

Two questions are answerable from that, and each answer carries a citation: what this record read on a given day, and whether it differed from the day before. A run is recorded whether or not anything differed, because “unchanged” is a statement about every day in between, and only an observation on each of those days makes it one.

It reports what documents say and when they changed. It does not interpret — no recommendations, and no assessment of what any document requires of anyone.

What one entry says now, and how it is held — the tracker below on this page.
What a document said on a dated day — the archive, retained copies with their SHA-256 digests, each filed under the date it was retrieved.
What changed and when, as a page or as a feed — recorded changes, and the changes feed.

Ordered by the population each answer is about — one entry, then the entries with a retained copy, then the whole series. That is a stated rule, not a ranking, and no count is printed beside a path so that no second ordering can be read from the numerals.

Integrity

A daily integrity root is published, with the commands that recompute it from the published data.

Verify this record

Last updated: 18 September 2026