GxPlex

Class (as stated): authority guidance

12 of 86 tracked instruments.

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status unknown 3 frozen 5 final 2 in-force 2

Ordered by the lifecycle the values themselves name.

Jurisdiction International 5 EU 4 US 2 UK 1

Ordered by count, then alphabetically.

Subject (as stated) no self-stated subject 4 artificial intelligence 2 security 1 computerised systems 2 manufacturing 1 data integrity 1 validation 1 good manufacturing practice 1

Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.

Class (as stated) no self-stated class 43 consensus standard 24 authority guidance 12 (active — select again to clear) legal act 7

The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.

Two facets compose at a time.

Showing 12 of 86 instruments. Clear all filters

Class (as stated): authority guidance — 12 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
Instrument Authority Jurisdiction Status Last verified Last changed Source
Annex 11 concept paper European Medicines Agency EU not yet verified awaiting link (opens in new tab)
Annex 15 revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme International not yet verified awaiting link (opens in new tab)
EU GMP Annex 11 European Commission EU in force verified 2026-07-30 link (opens in new tab) · retrieved
EU GMP Annex 15 European Commission EU in force tool-read 2026-07-31 link (opens in new tab) · retrieved
EU GMP Annex 22 European Commission EU not yet verified awaiting link (opens in new tab)
FDA guidance agenda US Food and Drug Administration US not yet verified frozen register states no status link (opens in new tab)
GAMP AI Guide ISPE International not yet verified frozen paywalled — progression tracked link (opens in new tab)
MHRA data integrity Medicines and Healthcare products Regulatory Agency UK final tool-read 2026-07-31 link (opens in new tab) · retrieved
NIST SP 800-82 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
PIC/S Annex 11 Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen listing only link (opens in new tab)
PIC/S GMP Guide Pharmaceutical Inspection Co-operation Scheme International not yet verified frozen paywalled — progression tracked link (opens in new tab)
WHO data management World Health Organization International not yet verified frozen listing only link (opens in new tab)

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