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,…
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…
