GxPlex

Source archive

A retained-document archive. Each record fixes one document at one moment — the URL it was retrieved from, the date, a SHA-256 of the file as retrieved, and where an independent archive holds a copy. Records are written one at a time, when a document is captured or when a link recorded for a source is found dead: 18 records across 18 sources.

Documents are linked, never rehosted. The hash is the integrity claim: it lets anyone confirm that the file they hold is the file that was read on that date.

This is not the observation series. A record's address here — /archive/<source>/<version>/ — names one retained retrieval, not a day in a series, and the SHA-256 on it was computed from that retrieval's own bytes rather than drawn from the series. This site separately retrieves each tracked source on a repeating schedule and records one observation per fetch. Not every fetch produces a digest: 12,646 of 18,012 recorded observations carry a content_hash. That series is published in full at /api/v1/observations.json, and where a source has an instrument page and its most recent observation recorded a hash, that hash appears on the page: 90 of the 150 sources in the series. No hash appears on a page for the other 60 — 18 are observed under an id this site publishes no instrument page for; of those that have one, 6 have never recorded a hash and 36 recorded their most recent one at an earlier observation.

5 original link(s) no longer resolve. They are flagged below and the archive link is the remaining route to the document.

EMA AI reflection paper

This source also holds 2 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for EMA AI reflection paper
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — e659bb5cf40fbc50…

EU AI Act

This source also holds 2 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for EU AI Act
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 6cc5293ea7c57385…

EU GMP Annex 11

This source also holds 3 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for EU GMP Annex 11
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 00546070e1a895c6…

EU GMP Annex 22

This source also holds 3 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for EU GMP Annex 22
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 00546070e1a895c6…

EU IVDR

Records retained for EU IVDR
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 6b539c0e37c8b60f…

EU MDR

This source also holds 2 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for EU MDR
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 93520cdf85bbed9b…

FDA AI guidance

This source also holds 4 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for FDA AI guidance
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 30c8145979fec465…

FDA CDRH AI/ML

Records retained for FDA CDRH AI/ML
VersionRetrieved OriginalArchiveSHA-256
URL dead as of 2026-07-29 2026-07-29 dead link — —

FDA CSA

Records retained for FDA CSA
VersionRetrieved OriginalArchiveSHA-256
URL dead as of 2026-07-29 2026-07-29 dead link archived (opens in new tab) —

FDA data integrity

Records retained for FDA data integrity
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — c81adfe76025499f…

FDA Digital Health Center of Excellence

Records retained for FDA Digital Health Center of Excellence
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 12be3465fe8bcc81…

FDA guidance agenda

This source also holds 2 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for FDA guidance agenda
VersionRetrieved OriginalArchiveSHA-256
URL dead as of 2026-07-29 2026-07-29 dead link — —

FDA PCCP

Records retained for FDA PCCP
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — fc317e8a7ce4bbf8…

Health Canada ML

This source also holds 2 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for Health Canada ML
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — 9fdd59bac7421c19…

ICH E6(R3)

Records retained for ICH E6(R3)
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — c19774b8c67c6c22…

ich-q10 — removed from scope on . removed from scope — a quality-management instrument, cited by tracked instruments but not itself governing computerised systems The snapshots below stay: a retained snapshot outlives a scope decision, which is why it was retained.

Records retained for ich-q10
VersionRetrieved OriginalArchiveSHA-256
2026-07-29 2026-07-29 live (opens in new tab) · retrieved — c19774b8c67c6c22…

MHRA AI

This source also holds 8 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for MHRA AI
VersionRetrieved OriginalArchiveSHA-256
URL dead as of 2026-07-29 2026-07-29 dead link — —

MHRA AI Airlock

This source also holds 9 distinct retained readings in the observation series, over a different referent from the records below: compare any two of them.

Records retained for MHRA AI Airlock
VersionRetrieved OriginalArchiveSHA-256
URL dead as of 2026-07-29 2026-07-29 dead link — —

Retained readings, and comparing two of them

Separately from the records above, this site retrieves each tracked source on a repeating schedule and, where text can be extracted, retains the normalised text it hashed. Where two of those readings differ, the difference between them can be computed.

The two digests are of different things. A SHA-256 above is over one retrieved file, byte for byte. A digest on a comparison timeline is over the normalised text of one observation, with scripts, comments and page chrome removed and tags stripped before hashing. Neither reproduces the other, and a comparison drawn across them would be a comparison of a file with a projection of a page.

Two or more distinct retained readings are held for 85 of the 132 tracked entries. Every pair of them carries either the difference or the condition that refused it, and the conditions are stated at the comparison index.

Tracked rows holding two or more distinct retained readings
SourceRetained readings FirstLatest
21 CFR Part 11 12
21 CFR Part 211 10
21 CFR Part 820 (QMSR) 10
Annex 11 concept paper 2
Annex 15 revision concept paper 2
ASTM E2363 3
ASTM E2500 3
ASTM E2537 2
CISA CPG 2.0 2
DI revision concept paper 2
EMA AI reflection paper readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
EMA CT computerised systems 2
EMA data quality framework 2
EMA work programme readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
EU AI Act 2
EU GMP Annex 1 2
EU GMP Annex 10 2
EU GMP Annex 11 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 3
EU GMP Annex 11 (draft) 2
EU GMP Annex 12 2
EU GMP Annex 13 2
EU GMP Annex 14 2
EU GMP Annex 15 2
EU GMP Annex 16 2
EU GMP Annex 17 2
EU GMP Annex 19 2
EU GMP Annex 2 2
EU GMP Annex 21 2
EU GMP Annex 22 3
EU GMP Annex 3 2
EU GMP Annex 6 2
EU GMP Annex 7 2
EU GMP Annex 8 2
EU GMP Annex 9 2
EU GMP Chapter 1 2
EU GMP Chapter 2 2
EU GMP Chapter 3 2
EU GMP Chapter 4 2
EU GMP Chapter 4 (draft) 2
EU GMP Chapter 5 2
EU GMP Chapter 6 2
EU GMP Chapter 7 2
EU GMP Chapter 8 2
EU GMP Chapter 9 2
EU Machinery Regulation 2
EU MDR 2
FDA AI device list 3
FDA AI guidance readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 4
FDA device cybersecurity readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
FDA device cybersecurity (2026) 3
FDA electronic systems (clinical) 2
FDA GMLP guiding principles 2
FDA guidance agenda readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
FDA/EMA AI principles 2
GAMP 5 2nd Ed 5
GAMP AI Guide 7
Health Canada ML 2
IEC 62304 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
IEC 81001-5-1 3
ISO 14971 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
ISO/IEC 22989 2
ISO/IEC 24028 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 18
ISO/IEC 27017:2026 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 2
ISO/IEC 38507 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 20
ISO/IEC 42005 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 21
ISO/IEC 5259 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 18
ISO/IEC SC 42 readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 10
ISPE GAMP RDI 5
MHRA AI readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 8
MHRA AI Airlock 9
MHRA data integrity readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 9
NIST agent standards 10
NIST AI 600-1 2
NIST AI RMF readings interleave — a digest recurs after a later one first appeared, so these are not a sequence of versions 3
NIST AI RMF Playbook 2
NIST CSF 2.0 2
NIST SP 800-82 2
NISTIR 8183 2
NMPA portal 4
PIC/S GMP Guide 2
PIC/S PI 041 2
PMDA AI 36
WHO AI health 2
WHO computerised systems 2
WHO data management 46

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