GxPlex

Quality Risk Management

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
2

International

Defined in
ICH Q9(R1)
no clause given: text withheld (over the cap: its term and text are 27 words)
Rows printing it in a normative sentence
1
Rows printing it in a title
1
Rows printing it in body
4

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
0
Rows printing it in body
2

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

20 sentences in 9 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

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

In body

13 occurrences in 8 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

62 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. 4 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 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
797a882ba0ea001
53742d793b68 (current)000
ac0054416554001
749c40132375001
f110d5d47c11001
bf56cba791d8001
3db9896305a6001
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)021
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)040
EU GMP Annex 22
First observedTextDefinedIn normative sentencesIn body
797a882ba0ea001
07dc6a9975d1 unmeasured: the retained text opens with a PDF file signature ('%PDF-')not measurednot measurednot measured
f8b98469078e (current)010
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)032
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)010
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)040
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)030
FDA AI guidance
First observedTextDefinedIn normative sentencesIn body
61d4603ff66e000
088a7a37c55d000
630bd27c7b42000
5c61f4c6351d (current)001
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)002
ICH Q12
First observedTextDefinedIn normative sentencesIn body
206fc2d61445 (current)011
ICH Q13
First observedTextDefinedIn normative sentencesIn body
06273204f50b (current)002
ICH Q14
First observedTextDefinedIn normative sentencesIn body
5e9388123e17 (current)002
ICH Q9(R1)
First observedTextDefinedIn normative sentencesIn body
57c484f5daed (current)102

Feed

/atom/term/quality-risk-management.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
EU GMP Annex 11trueopentruetrue
EU Cybersecurity Acttrueopentruetrue
FDA electronic systems (clinical)trueopentruetrue
EU Machinery Regulationtrueopentruetrue
EU Cyber Resilience Acttrueopentruetrue
21 CFR Part 820 (QMSR)trueopentruetrue
EU NIS2 Directivetrueopentruetrue
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.

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