Tracker → EU
EU GMP Annex 11
EudraLex Volume 4, Annex 11 — Computerised Systems
not yet verified
Not yet verified. The status of this instrument has not been
confirmed against its primary source. It is recorded as unknown rather than
estimated. Consult the
primary source directly.
- Authority
- European Commission
- Jurisdiction
- EU
- Status
- not yet verified
- Effective date
- —
- Last changed
- —
- Last verified
- : not yet verified
- Watch cadence
- weekly
- Crawlable
- yes · renders server-side
- Text licence
- freely reproducible
- Primary source
- Primary source (health.ec.europa.eu)
- Topics
- computerised systems · GMP · electronic records
Current status
Status not yet verified against the primary source. Recorded as unknown rather than estimated.
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
NEEDS VERIFICATION. The regulatory status of this instrument has not yet been
confirmed against its primary source. It is recorded as unknown rather than
estimated. See /methodology for what verification means here.
Observation history
No observations recorded yet.
Other instruments addressing the same subjects
A citation index only: both documents address the subject. This
states no relationship between their requirements.
Sources