GxPlex

Requirements

shared term, no equivalence asserted

The rows below print this term in 3 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.

EU

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
8
Rows printing it in a title
0
Rows printing it in body
9

International

Defined in
ICH Q9(R1)
no clause given: text withheld (over the cap: its term and text are 41 words)
Rows printing it in a normative sentence
1
Rows printing it in a title
0
Rows printing it in body
3

US

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
0
Rows printing it in body
5

This form is printed by the tracked documents, each as a document defines it. The index’s key is requirements (the definitions derivation’s fold: case set aside, spaces collapsed; each form is matched exactly as printed). 1 observed text defines 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

16 sentences in 11 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

38 occurrences in 17 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

108 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. 22 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 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)004
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)001
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)011
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27012
9d16077b1d3b (current)012
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)012
EU GMP Annex 1
First observedTextDefinedIn normative sentencesIn body
2f3d52a59156 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1d99797d3b8b (current)010
EU GMP Annex 11
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea002
53742d793b68 (current)010
ac0054416554002
749c40132375002
f110d5d47c11002
bf56cba791d8002
3db9896305a6002
EU GMP Annex 11 (draft)
First observedTextDefinedIn normative sentencesIn body
0e885238d69a unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
7a8b8a6e95d5 (current)023
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 22
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea002
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
f8b98469078e (current)000
EU GMP Annex 6
First observedTextDefinedIn normative sentencesIn body
10131cf8966a unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1787513e049d (current)040
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)002
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8003
82fb682a6c54 (current)003
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c8003
fab624c8e1dc (current)003
EU NIS2 Directive
First observedTextDefinedIn normative sentencesIn body
023dc18395dc (current)011
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)000
d34d8c706d88022
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)022
FDA guidance agenda
First observedTextDefinedIn normative sentencesIn body
f5e8806992b5000
ae6842a2cdd8 (current)002
FDA Part 11 scope
First observedTextDefinedIn normative sentencesIn body
a5590943862c (current)004
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)002
ICH Q13
First observedTextDefinedIn normative sentencesIn body
06273204f50b (current)002
ICH Q9(R1)
First observedTextDefinedIn normative sentencesIn body
57c484f5daed (current)100
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)001
21 CFR Part 211
First observedTextDefinedIn normative sentencesIn body
393b48f902b8010
5997ebbb6661010
9d7b6d9aa4e1010
18e04a0c925a010
1e7f13684129010
f24b92ecdf42010
b670ac9656b7010
bc527e48bcd8010
4edb9480421c010
cd3e1c0c936b010
75605421c92f (current)010
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c687003
fa65ecef3a81003
8ee8e1aad0a5003
f3605b69e136003
baa155d883e3003
ac6e97a3c75d003
bb66b9cbb2c4003
0e1bbcb2d14d003
0eb9eade1868003
94a77d5625e8003
ca64082d7f23 (current)003

Feed

/atom/term/requirements.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
ICH Q9(R1)trueopentruetrue
EU Cybersecurity Acttrueopentruetrue
EU Machinery Regulationtrueopentruetrue
21 CFR Part 11trueopentruetrue
EU IVDRtrueopentruetrue
EU MDRtrueopentruetrue
FDA device cybersecuritytrueopentruetrue
FDA device cybersecurity (2026)trueopentruetrue
EU GMP Annex 11trueopentruetrue
EU AI Acttrueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU NIS2 Directivetrueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
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: