GxPlex

EU GMP Annex 11

EudraLex Volume 4, Annex 11 — Computerised Systems

withdrawn

Last verified: Last observed: no observation recorded Tier: 1 · Sector: pharma
Authority
European Commission
Jurisdiction
EU
Status
withdrawn
Effective date
—
Last changed
—
Last verified
:
Watch cadence
weekly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) health.ec.europa.eu
Topics
computerised systems · GMP · electronic records

Current status#

Recorded as withdrawn against the primary source on 2026-07-28. See the evidence record for the text that supported it.

Scope#

Annex to the EU GMP guide addressing computerised systems used in regulated manufacturing. A revision has been under public consultation.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

Cite this instrument

Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.

Plain text

GxPlex. EudraLex Volume 4, Annex 11 — Computerised Systems [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/eu-gmp-annex-11 Primary source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en

BibTeX

@misc{gxplexinstrumenteugmpannex11,
  author       = {{GxPlex}},
  title        = {{EudraLex Volume 4, Annex 11 — Computerised Systems}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/eu-gmp-annex-11}},
  urldate      = {2026-07-28},
  url          = {https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en}
}

APA

GxPlex. (2026). EudraLex Volume 4, Annex 11 — Computerised Systems [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/eu-gmp-annex-11

Observation history

No observations recorded yet.

Archived versions

Other instruments addressing the same subjects

A citation index only: both documents address the subject. This states no relationship between their requirements.

Change history

Sources

Last updated: