GxPlex

Citation concordance

An index of sections in different instruments that address the same subject, so a reader consulting one can find the others.

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

Access control

Audit trail

Backup

Data integrity

Electronic record

Electronic signature

Human oversight

Risk management

Validation

Where each subject sits in the text

A subject 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.

A subject is matched verbatim: the words as written, an optional trailing s, ignoring case, on word boundaries. No synonym, no stem, no paraphrase. 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 subject is not in it
in the retained text, outside the scope passage
the subject 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 subject 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 subject sits, across the texts read

Subjects in the order they appear above; values in alphabetical order by label. Every row sums to the 94 retained texts read.
Subject absent from the retained textin the retained text, outside the scope passagein the retained text; no scope passage locatedwithin the scope passage
Access control 82570
Audit trail 83470
Backup 80680
Data integrity 82390
Electronic record 84271
Electronic signature 88141
Human oversight 90130
Risk management 468382
Validation 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 Subjects 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 citation list under each subject was generated on and names the sources that carried a quotable span for that subject on that day. The two readings were taken at different times over a store that keeps growing, so they are not the same measurement and are not presented as one; the later of the two is the one in this section.

Compared subject by subject: for 9 of 9 the count of texts holding the subject now exceeds the length of that subject’s list, for 0 it falls short of it, and the rest agree.

Last updated: