GxPlex

Quality

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
28
Rows printing it in a title
3
Rows printing it in body
24

International

Defined in
ICH Q9(R1)
no clause given: text withheld (end not delimited: the text before the next definition read does not end with a full stop or a semicolon)
Rows printing it in a normative sentence
4
Rows printing it in a title
1
Rows printing it in body
6

US

Defined in
no current text of a row of this jurisdiction defines it
Rows printing it in a normative sentence
4
Rows printing it in a title
5
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 quality (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

113 sentences in 36 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

9 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

246 occurrences in 42 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

88 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. 69 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.

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 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)0563
DI revision concept paper
First observedTextDefinedIn normative sentencesIn body
208b17ec5cbe001
4f4cdfc13143 (current)001
EU AI Act
First observedTextDefinedIn normative sentencesIn body
58dbc3006d27002
9d16077b1d3b (current)002
EU Cyber Resilience Act
First observedTextDefinedIn normative sentencesIn body
9206a43954eb (current)001
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)033
EU GMP Annex 10
First observedTextDefinedIn normative sentencesIn body
1bf6c7c62112 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
f7881a52f0ad (current)001
EU GMP Annex 11
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea004
53742d793b68 (current)010
ac0054416554004
749c40132375004
f110d5d47c11004
bf56cba791d8004
3db9896305a6004
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)034
EU GMP Annex 13
First observedTextDefinedIn normative sentencesIn body
48f21f2e4f1b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
c4635c9c95ba (current)010
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)022
EU GMP Annex 15
First observedTextDefinedIn normative sentencesIn body
50a728365a3b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
db59da980bed (current)023
EU GMP Annex 16
First observedTextDefinedIn normative sentencesIn body
c69969906e63 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
2f7bb1a97c67 (current)042
EU GMP Annex 17
First observedTextDefinedIn normative sentencesIn body
d15b6167fee9 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
507358780b13 (current)021
EU GMP Annex 2
First observedTextDefinedIn normative sentencesIn body
053f731102ad unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
c1a1d8a7fee4 (current)021
EU GMP Annex 21
First observedTextDefinedIn normative sentencesIn body
45769b002c01 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6e2055f21776 (current)032
EU GMP Annex 22
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea004
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
f8b98469078e (current)010
EU GMP Annex 3
First observedTextDefinedIn normative sentencesIn body
2cb8ccdb053c unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
743cfcdd11a7 (current)023
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)001
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)011
EU GMP Annex 8
First observedTextDefinedIn normative sentencesIn body
04e1593f805c unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
1be3d183419f (current)022
EU GMP Chapter 1
First observedTextDefinedIn normative sentencesIn body
0c75116285b8 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
cfea967f8325 (current)01216
EU GMP Chapter 2
First observedTextDefinedIn normative sentencesIn body
6d54bcfeb8e7 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
313242556edd (current)067
EU GMP Chapter 3
First observedTextDefinedIn normative sentencesIn body
dccc2d038791 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
c0432468bd32 (current)020
EU GMP Chapter 4
First observedTextDefinedIn normative sentencesIn body
ef49f58a80fe unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
b9143ae11461 (current)040
EU GMP Chapter 4 (draft)
First observedTextDefinedIn normative sentencesIn body
85a680107f4d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
8f04120f403b (current)050
EU GMP Chapter 5
First observedTextDefinedIn normative sentencesIn body
f30eb798ed40 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
172395cf624f (current)090
EU GMP Chapter 6
First observedTextDefinedIn normative sentencesIn body
2ebf88652dc3 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6ec505fc00ef (current)0104
EU GMP Chapter 7
First observedTextDefinedIn normative sentencesIn body
723340abc9bd unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d5d92da2b929 (current)012
EU GMP Chapter 8
First observedTextDefinedIn normative sentencesIn body
6af0146c0d0b unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
880033e05d95 (current)071
EU GMP Chapter 9
First observedTextDefinedIn normative sentencesIn body
baf7d10904f7 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
6be6e232dd4c (current)010
EU IVDR
First observedTextDefinedIn normative sentencesIn body
903e40aaebe6 (current)012
EU Machinery Regulation
First observedTextDefinedIn normative sentencesIn body
1fc20ae2ffd8001
82fb682a6c54 (current)001
EU MDR
First observedTextDefinedIn normative sentencesIn body
14d00b77d5c8012
fab624c8e1dc (current)012
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e002
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)014
FDA AI device list
First observedTextDefinedIn normative sentencesIn body
7d8bfb6d13ca006
a55b6f369034006
f0d90446093e (current)006
FDA CSA
First observedTextDefinedIn normative sentencesIn body
4843091843f0 (current)004
FDA device cybersecurity
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca (current)003
d34d8c706d880212
FDA device cybersecurity (2026)
First observedTextDefinedIn normative sentencesIn body
b52b706d5cca003
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
d34d8c706d88 (current)0212
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)013
FDA ETP
First observedTextDefinedIn normative sentencesIn body
6b01e1d72618 (current)001
FDA guidance agenda
First observedTextDefinedIn normative sentencesIn body
f5e8806992b5000
ae6842a2cdd8 (current)004
FDA Part 11 scope
First observedTextDefinedIn normative sentencesIn body
a5590943862c (current)005
FDA process analytical framework
First observedTextDefinedIn normative sentencesIn body
2104fa729111 (current)002
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)049
ICH Q13
First observedTextDefinedIn normative sentencesIn body
06273204f50b (current)0310
ICH Q14
First observedTextDefinedIn normative sentencesIn body
5e9388123e17 (current)005
ICH Q2(R2)
First observedTextDefinedIn normative sentencesIn body
bb656b9e84a8 (current)011
ICH Q9(R1)
First observedTextDefinedIn normative sentencesIn body
57c484f5daed (current)1639
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)007
21 CFR Part 820 (QMSR)
First observedTextDefinedIn normative sentencesIn body
8b8ac787c687013
fa65ecef3a81013
8ee8e1aad0a5013
f3605b69e136013
baa155d883e3013
ac6e97a3c75d013
bb66b9cbb2c4013
0e1bbcb2d14d013
0eb9eade1868013
94a77d5625e8013
ca64082d7f23 (current)013

Feed

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