GxPlex

Agency

shared term, no equivalence asserted

The rows below print this term in 5 jurisdictions, set side by side by each row’s own jurisdiction field, in code-unit order of that field. Each definition is kept apart under its own text, and quoted where the term and its text together sit under the quote cap: 1 of 1 definition in this view is quoted and 0 are withheld with the reason. No reading here says that two of them agree or differ.

Canada

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
0
Rows printing it in a title
0
Rows printing it in body
1

EU

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
11
Rows printing it in a title
0
Rows printing it in body
11

International

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
3
Rows printing it in a title
0
Rows printing it in body
7

UK

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
0
Rows printing it in a title
0
Rows printing it in body
3

US

Defined in
21 CFR Part 11
no clause given ( 2 ): the Food and Drug Administration.
Rows printing it in a normative sentence
6
Rows printing it in a title
0
Rows printing it in body
12

This form is printed by the tracked documents, each as a document defines it. The index’s key is agency (the definitions derivation’s fold: case set aside, spaces collapsed; each form is matched exactly as printed). 13 observed texts define it. Counts below are over each row’s current text, the 81 of 126 current texts the derivation read; a title is read for every one of the 132 tracked rows.

Defined

1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.

In normative sentences

49 sentences in 20 current texts printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.

Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.

In titles

0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.

No tracked row’s title prints it.

In body

189 occurrences in 34 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.

Co-occurrence

80 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row. 182 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).

History

Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.

EMA AI reflection paper
First observedTextDefinedIn normative sentencesIn body
eb42a10342ad002
863f5ab39635002
3e7ec4b884ce002
36c41987de4a (current)002
Annex 11 concept paper
First observedTextDefinedIn normative sentencesIn body
17bed942038f unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6d68d146b07c (current)010
EMA CT computerised systems
First observedTextDefinedIn normative sentencesIn body
90f72782b398 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
ebaf707c409d (current)012
EMA data quality framework
First observedTextDefinedIn normative sentencesIn body
e2ad4536a9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
4d30b7bae7dd (current)017
Annex 15 revision concept paper
First observedTextDefinedIn normative sentencesIn body
08b4462d76fa unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
acd195a087c3 (current)002
DI revision concept paper
First observedTextDefinedIn normative sentencesIn body
208b17ec5cbe014
4f4cdfc13143 (current)014
EMA work programme
First observedTextDefinedIn normative sentencesIn body
4d557437981e00107
db02caebc16500107
4da80e1b85de (current)00107
c4ee78a4aa6800104
0149db50a85d00106
cff4d1ac4ab400106
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27023
9d16077b1d3b (current)023
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)022
EU Cybersecurity Act
First observedTextDefinedIn normative sentencesIn body
1fe6027daa2c (current)0110
Regulation (EU) 2026/1744
First observedTextDefinedIn normative sentencesIn body
92eb86f25281 (current)001
EU GMP Annex 14
First observedTextDefinedIn normative sentencesIn body
6eabc41e8879 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
ea32c21545ee (current)010
EU GMP Annex 7
First observedTextDefinedIn normative sentencesIn body
e6dfb22ae579 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fd6b0dfbb7fd (current)010
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)030
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8002
82fb682a6c54 (current)002
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c8021
fab624c8e1dc (current)021
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)035
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e000
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)0124
FDA data integrity
First observedTextDefinedIn normative sentencesIn body
c30f5ac99d82 (current)001
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d88052
FDA device cybersecurity (2026)
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca000
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d34d8c706d88 (current)052
FDA electronic systems (clinical)
First observedTextDefinedIn normative sentencesIn body
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
74c586849092 (current)023
FDA GMLP guiding principles
First observedTextDefinedIn normative sentencesIn body
ef0dfb4023b7001
2091aa6e2741 (current)001
FDA Part 11 scope
First observedTextDefinedIn normative sentencesIn body
a5590943862c (current)0615
FDA postmarket cybersecurity
First observedTextDefinedIn normative sentencesIn body
d1889be52428 (current)001
FDA process analytical framework
First observedTextDefinedIn normative sentencesIn body
2104fa729111 (current)001
Health Canada ML
First observedTextDefinedIn normative sentencesIn body
2988351a1019001
f34e637e74cb (current)001
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)011
ICH Q13
First observedTextDefinedIn normative sentencesIn body
06273204f50b (current)021
ICH Q14
First observedTextDefinedIn normative sentencesIn body
5e9388123e17 (current)001
ICH Q2(R2)
First observedTextDefinedIn normative sentencesIn body
bb656b9e84a8 (current)001
ICH Q9(R1)
First observedTextDefinedIn normative sentencesIn body
57c484f5daed (current)001
MHRA AI
First observedTextDefinedIn normative sentencesIn body
110d6c8e7c56001
d4b6bb0450a8001
0d4b2abb3a4f001
8fc70fdfe3a5001
95ff73c7efa2001
21fde7c052b4001
d722379e4120001
f61cf3af5063001
adda145eadf9 (current)001
MHRA AI Airlock
First observedTextDefinedIn normative sentencesIn body
7337fc5e71ae001
6e98d69dcbc7001
5ccba04e90a2001
aa1a23f2db97001
dd2f48968ac3001
6f27b489239b001
d1d2dd4818e2001
a16f7063df22001
53985e50d069001
2cf39acc83b7001
0465b20f61c7 (current)001
MHRA data integrity
First observedTextDefinedIn normative sentencesIn body
c330704e7caa010
13971812bd57010
6903993ae01b010
aadc8bf62498010
9a0948cb5e5b010
5f23d775ccaa010
f4ddeaad589b010
fe6722320c02010
ced856cd0b5a010
c59c1f4d8377 (current)001
NIST AI 600-1
First observedTextDefinedIn normative sentencesIn body
a5ad5867c187 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
caa03fc84948 (current)001
21 CFR Part 11
First observedTextDefinedIn normative sentencesIn body
f0554d5c3fab102
6a4d277ca4f8102
95bf4a66f2d4102
98ed07f87cdd102
15f94377c4fc102
9269c75204ff102
4d93ac00b602102
825750c5633d102
39db0dd17f53102
244eba4196bb102
605180a389c7102
ed1c9acbb776102
bbbd805d0905 (current)101
21 CFR Part 211
First observedTextDefinedIn normative sentencesIn body
393b48f902b8012
5997ebbb6661012
9d7b6d9aa4e1012
18e04a0c925a012
1e7f13684129012
f24b92ecdf42012
b670ac9656b7012
bc527e48bcd8012
4edb9480421c012
cd3e1c0c936b012
75605421c92f (current)011
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c687012
fa65ecef3a81012
8ee8e1aad0a5012
f3605b69e136012
baa155d883e3012
ac6e97a3c75d012
bb66b9cbb2c4012
0e1bbcb2d14d012
0eb9eade1868012
94a77d5625e8012
ca64082d7f23 (current)011

Feed

/atom/term/agency.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.

How this page is derived

From the terms-index derivation’s current version, first derived on , read from state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on the derivation methods page, which lists every version of each with the day it was first derived: a change there is a change of method, never a change in a text.

Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.

Rights envelope — how this record handles the text of each entry listed
Entrytext_retainedlicence_classquote_allowedsnapshot_available
21 CFR Part 11trueopentruetrue
EU Cybersecurity Acttrueopentruetrue
EU Machinery Regulationtrueopentruetrue
EU IVDRtrueopentruetrue
EU MDRtrueopentruetrue
EU AI Acttrueopentruetrue
EU GMP Annex 22trueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU NIS2 Directivetrueopentruetrue
ICH Q9(R1)trueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
ICH Q13trueopentruetrue
EU GMP Chapter 4trueopentruetrue

One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.

Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.

Last updated: