GxPlex

Status: in-force · Subject (as stated): computerised systems

1 of 86 tracked instruments.

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

Status frozen 3 final 1 in-force 1 (active — select again to clear)

Ordered by the lifecycle the values themselves name.

Subject (as stated) no self-stated subject 3 artificial intelligence 1 medical devices 2 computerised systems 1 (active — select again to clear) manufacturing 1 validation 1 electronic records 1 electronic signatures 1
+2 more good manufacturing practice 1 in vitro diagnostic 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.

Two facets compose at a time; the other groups return when one is cleared.

Showing 1 of 86 instruments. Clear all filters

Status: in-force · Subject (as stated): computerised systems — 1 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
EU GMP Annex 11 European Commission EU in force verified 2026-07-30 link (opens in new tab) · retrieved

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