GxPlex

Act

shared term, no equivalence asserted

The rows below print this term in 4 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: 0 of 1 definition in this view are quoted and 1 is 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
2
Rows printing it in a title
3
Rows printing it in body
6

International

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

US

Defined in
21 CFR Part 11
no clause given ( 1 ): text withheld (over the cap: its term and text are 16 words)
Rows printing it in a normative sentence
7
Rows printing it in a title
0
Rows printing it in body
10

This form is printed by the tracked documents, each as a document defines it. The index’s key is act (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

38 sentences in 10 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

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

In body

117 occurrences in 18 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

59 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. 73 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.

EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27019
9d16077b1d3b (current)019
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)006
EU Cybersecurity Act
First observedTextDefinedIn normative sentencesIn body
1fe6027daa2c (current)004
Regulation (EU) 2026/1744
First observedTextDefinedIn normative sentencesIn body
92eb86f25281 (current)023
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8001
82fb682a6c54 (current)001
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)002
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e005
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)045
FDA clinical decision support
First observedTextDefinedIn normative sentencesIn body
ad537c73610a (current)006
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)001
d34d8c706d8802037
FDA device cybersecurity (2026)
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca001
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d34d8c706d88 (current)02037
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)026
FDA guidance agenda
First observedTextDefinedIn normative sentencesIn body
f5e8806992b5000
ae6842a2cdd8 (current)0011
FDA Part 11 scope
First observedTextDefinedIn normative sentencesIn body
a5590943862c (current)006
Health Canada ML
First observedTextDefinedIn normative sentencesIn body
2988351a1019003
f34e637e74cb (current)003
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)010
NIST AI RMF
First observedTextDefinedIn normative sentencesIn body
8afebcc0941a000
c240f2675bd3000
4c10dc03228b (current)002
NISTIR 8183
First observedTextDefinedIn normative sentencesIn body
92b7bfe588c4 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
fe392d207918 (current)010
21 CFR Part 11
First observedTextDefinedIn normative sentencesIn body
f0554d5c3fab113
6a4d277ca4f8113
95bf4a66f2d4113
98ed07f87cdd113
15f94377c4fc113
9269c75204ff113
4d93ac00b602113
825750c5633d113
39db0dd17f53113
244eba4196bb113
605180a389c7113
ed1c9acbb776113
bbbd805d0905 (current)113
21 CFR Part 211
First observedTextDefinedIn normative sentencesIn body
393b48f902b8033
5997ebbb6661033
9d7b6d9aa4e1033
18e04a0c925a033
1e7f13684129033
f24b92ecdf42033
b670ac9656b7033
bc527e48bcd8033
4edb9480421c033
cd3e1c0c936b033
75605421c92f (current)033
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c687039
fa65ecef3a81039
8ee8e1aad0a5039
f3605b69e136039
baa155d883e3039
ac6e97a3c75d039
bb66b9cbb2c4039
0e1bbcb2d14d039
0eb9eade1868039
94a77d5625e8039
ca64082d7f23 (current)039

Feed

/atom/term/act.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
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
EU MDRtrueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU IVDRtrueopentruetrue
EU NIS2 Directivetrueopentruetrue
ICH Q9(R1)trueopentruetrue
EU AI Acttrueopentruetrue
Regulation (EU) 2026/1744trueopentruetrue
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: