Annex 11

Definition

Annex 11 refers to the European Union (EU) guidelines concerning computerized systems used within regulated environments. These guidelines were devised to ensure that computer systems are reliable, secure, and capable of producing reproducible results in compliance with EU legislation. The primary objectives of Annex 11 are to ensure the integrity of data, guarantee the reliability of systems throughout their operational life, and ensure that the computerized systems in use are designed and maintained to be compliant with relevant regulatory requirements.