A C D E F G H I L P Q V
El Eu Ev

Electronic Record

Electronic record describes any combination of text, graphics, data, audio, images or other informational representations in digital format generated, modified, maintained, archived, accessed or distributed by a computer system (cf. 21 CFR Part 11).…
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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,…
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EU GMP Annex 22

EU GMP Annex 22 (“Artificial Intelligence”) is the planned AI annex to the EU GMP guideline (EudraLex Volume 4) – the first standalone set of rules for AI models in the manufacture of medicinal products and active substances, designed as…
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Evidence

Evidence is the documented proof – the records – that regulated activities were carried out as specified and that compliance is demonstrated. EU GMP Chapter 4 (Documentation) governs how these records are generated, controlled and retained.…
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