EU GMP Annex 11

EU GMP Annex 11 (“Computerised Systems”) is the European GMP annex for computerized systems: introduced in 1992, current in its 2011 version, part of EudraLex Vol. 4. Its principle divides the world of evidence in two: the application is validated, the IT infrastructure is qualified. Annex 11 requires a risk-based approach across the entire lifecycle – from supplier assessment and data controls to the audit trail, whose scope is to be defined on a risk basis (§9). It names the supplier’s competence and reliability as key factors in selection.

See also: Qualification, Verification, Audit Trail, Computerized System Validation.