EU Annex 11

The European Union (EU) recently revised Annex 11 of its "Volume 4: Good Manufacturing Practice" for human and veterinary medicines to address problems stemming from an increasingly computerized GMP environment, in which computer programming can potentially replace human judgment. Annex 11 provides guidance to help ensure electronic record integrity, which in turn helps ensure product safety.

While Annex 11 is not a regulation, it is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products. Ignoring EU Annex 11 could be as detrimental as ignoring the directives.

Annex 11: The EU's New Expectations for Regulated Computerized Systems
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