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.
- EMA CT computerised systems — 43 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span is not in the text read.
- FDA Part 11 scope — once in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
- 21 CFR Part 11 — 2 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
“backup”
These exact words occur in these sources.
- EU AI Act — once in the text retained on from the address that answered (opens in new tab) Paragraph 1
through technical redundancy solutions, which may include backup or fail-safe plans. High-risk AI systems
- EU Machinery Regulation — once in the text retained on from the address that answered (opens in new tab) (whole)
mode. Emergency stop devices shall be a backup to other safeguarding measures and not
- EU NIS2 Directive — 2 times in the text retained on from the address that answered (opens in new tab) Article 11
shall be equipped with redundant systems and backup working space to ensure continuity of
- 21 CFR Part 211 — 2 times in the text retained on from the address that answered (opens in new tab) § 211.68
of the computer or related system. A backup file of data entered into the
“data integrity”
These exact words occur in these sources.
- FDA data integrity — 4 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
- MHRA data integrity — 5 times in the text retained on from the address that answered (opens in new tab) (whole)
Guidance on GxP data integrity - GOV.UK Cookies on GOV.UK We use some essential
“electronic record”
These exact words occur in these sources.
- EMA CT computerised systems — 3 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
- FDA electronic systems (clinical) — 14 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
- FDA Part 11 scope — 4 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
- 21 CFR Part 11 — 3 times in the text retained on from the address that answered (opens in new tab) The recorded span is not shown: the recorded span does not contain these exact words.
“human oversight”
These exact words occur in these sources.
- CEN/CLC JTC 21 — once in the text retained on from the address that answered (opens in new tab) (whole)
and ensure compliance with risk management, transparency, human oversight, cybersecurity, and quality assurance requirements.
- EU AI Act — 15 times in the text retained on from the address that answered (opens in new tab) (whole)
and the provision of information to deployers, human oversight, and robustness, accuracy and cybersecurity.
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.
- EU AI Act: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints access controls once.
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.
- ISO/IEC SC 42: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Risk management 2 times.
- NIST agent standards: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints no form of them. An earlier text of the same entry, retained on from the address that answered (opens in new tab), held them.
- NIST AI RMF Playbook: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Risk Management once.
- PIC/S PI 011: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Risk Management 2 times.
- PIC/S PI 041: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Risk Management 2 times.
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.
- PIC/S PI 011: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Validation 6 times.
- PIC/S PI 041: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Validation 6 times.
- 21 CFR Part 11: the text retained on from the address that answered (opens in new tab) does not hold these exact words. It prints Validation once.
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
| Term | absent from the retained text | in the retained text, outside the scope passage | in the retained text; no scope passage located | within the scope passage |
|---|---|---|---|---|
| audit trail | 83 | 4 | 7 | 0 |
| backup | 80 | 6 | 8 | 0 |
| data integrity | 82 | 3 | 9 | 0 |
| electronic record | 84 | 2 | 7 | 1 |
| human oversight | 90 | 1 | 3 | 0 |
| access control (retired from the index ) | 82 | 5 | 7 | 0 |
| electronic signature (retired from the index ) | 88 | 1 | 4 | 1 |
| risk management (retired from the index ) | 46 | 8 | 38 | 2 |
| validation (retired from the index ) | 46 | 12 | 35 | 1 |
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.
| 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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