GxPlex

Shared publisher terms

Each term below is a run of words. In this build every entry listed under a term is one whose retained text holds those words exactly, so each term states one thing: these exact words occur in these sources.

contextual mapping — not a regulatory applicability determination The policy, stated once

How a term is matched: The words of the term as written, in the same order, with no letter, digit or underscore immediately before or after them, letter for letter in the same case. No plural, no other ending, no other capitalisation, no synonym, no stem. Each source is read in its newest retained text — the one named by its newest observation that names a text — and the address that answered is linked beside it with the day. A source whose text is not read here, because its licence position is restricted or because no text is retained, is listed as not measured and is counted neither as holding the words nor as lacking them.

5 terms in the index, with 15 listings in all, of 11 distinct entries: for 15 listings the text read holds the words, for 0 it does not, and 0 are not measured. Of the spans recorded with those listings, 7 are shown and 8 withheld, each with its reason. 4 terms were retired on ; the retired terms are listed at the end, each at its own address.

“audit trail”

These exact words occur in these sources.

“backup”

These exact words occur in these sources.

“data integrity”

These exact words occur in these sources.

“electronic record”

These exact words occur in these sources.

“human oversight”

These exact words occur in these sources.

Retired terms

Each term below was in the index until the day shown. Read as exact words, letter case kept, the retained text of at least one entry listed under it does not hold them, so the term was retired from the index. Each address still answers, here, with what was listed, each text that did not hold the words, and what that text prints instead.

“access control” — retired

Listed from under the heading “Access control”, with 4 entries: EU AI Act, EU Cyber Resilience Act, EU NIS2 Directive, NIST SP 800-82.

The correction: 2026-09-24.

“electronic signature” — retired

Listed from under the heading “Electronic signature”, with 4 entries: EMA CT computerised systems, FDA electronic systems (clinical), FDA Part 11 scope, 21 CFR Part 11.

  • FDA Part 11 scope: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Electronic Signatures 11 times, Electronic signatures once and electronic signatures 5 times.

The correction: 2026-09-24.

“risk management” — retired

Listed from under the heading “Risk management”, with 21 entries: CEN/CLC JTC 21, EU AI Act, EU Cyber Resilience Act, EU Cybersecurity Act, Regulation (EU) 2026/1744, EU GMP Annex 11, EU IVDR, EU MDR, EU NIS2 Directive, FDA Part 11 scope, Health Canada ML, ISO/IEC SC 42, NIST agent standards, NIST AI 600-1, NIST AI RMF, NIST AI RMF Playbook, NIST CSF 2.0, NIST SP 800-82, NISTIR 8183, PIC/S PI 011, PIC/S PI 041.

The correction: 2026-09-24.

“validation” — retired

Listed from under the heading “Validation”, with 14 entries: EMA CT computerised systems, EU AI Act, EU Cyber Resilience Act, Regulation (EU) 2026/1744, EU GMP Annex 11, EU IVDR, EU Machinery Regulation, EU MDR, FDA Part 11 scope, FDA software validation, PIC/S PI 011, PIC/S PI 041, 21 CFR Part 11, 21 CFR Part 211.

The correction: 2026-09-24.

Where each term sits in the text

A term can be printed in the passage a document opens as its scope, or elsewhere in that document, or nowhere in it. Each of those is a position in a document’s own arrangement, and a position is not a degree. What the difference between two of them is worth is the reader’s to settle. The values below carry no order of their own: they are listed alphabetically by their own label, and every cell beneath one is a count.

What was read

The record holds 132 tracked entries. Of those, 94 name a retained text in the observation store, and the reading below covers exactly them: for each, the text its newest observation carrying one names. Another 33 carry a licence position under which no text is read here at all — a restricted text is cited and linked, never excerpted — and 5 name no retained text, so nothing was searched for them and no absence is filed against them.

This section keeps the reading it was first published with, which is not the index’s: a term is matched verbatim, the words as written, an optional trailing s, ignoring case, on word boundaries. No synonym, no stem, no paraphrase. So a term can be counted here in a text the index above does not list it for, where that text prints it only with the s or only with other capitals. A scope passage opens where the text prints a structural marker of its own — an article number, a section symbol, a clause number — followed immediately by the word scope, and closes where that same marker form next appears followed by a capitalised word. Two printings are not read as openings, because each is how a publisher sets a contents list rather than a passage: one whose marker is followed by dot leaders within 40 characters, and one the next marker of the same form crowds within 60. Where a text prints markers of more than one form, the most specific form yielding a candidate is the one read, so an article number is read as an article and not as a bare clause number. Where the text prints more than one opening under all of that, nothing is published for it: several openings is an ambiguity, and choosing between them mechanically would be this record inventing which passage a publisher meant.

The values, and what each one says

absent from the retained text
the retained text was read and the term is not in it
in the retained text, outside the scope passage
the term is in the retained text, and every occurrence of it falls outside the passage that text opens as its scope
in the retained text; no scope passage located
the term is in the retained text, and this read located no passage opening as scope in that text — so neither of the two values above can be stated for it
within the scope passage
at least one occurrence falls inside the passage the text opens as its scope

Where each term sits, across the texts read

Terms in the index in the order they appear above, then the retired terms; values in alphabetical order by label. Every row sums to the 94 retained texts read.
Term absent from the retained textin the retained text, outside the scope passagein the retained text; no scope passage locatedwithin the scope passage
audit trail 83470
backup 80680
data integrity 82390
electronic record 84271
human oversight 90130
access control (retired from the index ) 82570
electronic signature (retired from the index ) 88141
risk management (retired from the index ) 468382
validation (retired from the index ) 4612351

The texts that open a passage this way

Of the 94 retained texts read, 17 print exactly one opening of that form, 75 print none, and 2 print more than one. That a text prints none is a fact about what this reader can locate in a retained text and not a statement about how a publisher arranges a document.

In identifier order. “Opens at” is the verbatim run of characters where the passage begins, not the whole of a heading, whose end this reader does not measure.
Text Opens at Terms inside the passage Read from
EMA CT computerised systems 2. Scope validation answered (opens in new tab) · retrieved
EMA data quality framework 4. Scope — answered (opens in new tab) · retrieved
EU AI Act Article 2 Scope — answered (opens in new tab) · retrieved
EU Cyber Resilience Act Article 2 Scope — answered (opens in new tab) · retrieved
EU Cybersecurity Act Article 1 Subject matter and scope — answered (opens in new tab) · retrieved
EU GMP Annex 2 1 Scope — answered (opens in new tab) · retrieved
EU GMP Annex 21 1. Scope — answered (opens in new tab) · retrieved
EU IVDR Article 1 Subject matter and scope — answered (opens in new tab) · retrieved
EU Machinery Regulation Article 2 Scope — answered (opens in new tab) · retrieved
EU MDR Article 1 Subject matter and scope risk management answered (opens in new tab) · retrieved
EU NIS2 Directive Article 2 Scope — answered (opens in new tab) · retrieved
ICH Q14 1.2 Scope — answered (opens in new tab) · retrieved
ICH Q2(R2) 1.2 Scope — answered (opens in new tab) · retrieved
ICH Q9(R1) 2. Scope risk management answered (opens in new tab) · retrieved
21 CFR Part 11 § 11.1 Scope electronic record · electronic signature answered (opens in new tab) · retrieved
21 CFR Part 211 § 211.1 Scope — answered (opens in new tab) · retrieved
21 CFR Part 820 (QMSR) § 820.1 Scope — answered (opens in new tab) · retrieved

2 print more than one opening, and nothing is published for them, because nothing mechanical says which passage a publisher meant: EU GMP Annex 1 1. Scope · 1 Scope; EU GMP Annex 11 (draft) 12.7. Scope · 13.1. Scope · 14.2. Scope · 16.5. Scope.

How this section and the lists above were measured

Every count in this section was taken from the retained texts this build read, on the day it read them.

The list of entries under each term in the index was generated on and names the sources whose text then carried a quotable span holding the term, with a trailing s allowed and capitals ignored; each span, and the section named with it, was recorded the same day. Each entry on the list whose text is read here is read again by this build, in the same retained text this section reads for it, under the index’s own rule: the count and the day beside it are that reading, and a recorded span is shown only where that text holds it. So the counts in the index and in this section are two readings of the same texts in one build, under two different rules, and are not presented as one measurement. The notices for the retired terms are not read again: each states the reading recorded when the term was retired, on .

Compared term by term: for 9 of 9 the count of texts holding the term here exceeds the length of that term’s list, for 0 it falls short of it, and the rest agree. The 9 include the 4 retired from the index, each compared with the list it was published with.

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