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
no clause given:
text withheld (over the cap: its term and text are 32 words)
Rows printing it in a normative sentence
2
Rows printing it in a title
0
Rows printing it in body
5
US
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
1
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
quality system (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.
no clause given (its definitions section's heading carries no number the clause anchors placed)Quality System:
text withheld (over the cap: its term and text are 32 words)
In normative sentences
17 sentences in 8 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.
29 occurrences in 16 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.
ICH Q12International2 occurrences; text first observed
4: 2
ICH Q13International3 occurrences; text first observed
3 where the heading before it is withheld
ICH Q14International2 occurrences; text first observed
13.2: 2
ICH Q2(R2)International1 occurrence; text first observed
annex-2/1.2: 1
ICH Q9(R1)International1 occurrence; text first observed
8: 1
Co-occurrence
70 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. 10 positions of this term
have no placed clause and share none
(a defining occurrence inside a sentence above is counted once under each).
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.
/atom/term/quality-system.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
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.