Electronic Records and Signatures per EU GMP Annex 11 | Scilife

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplementary documents of EU GMP rules. The growing use of computerized systems in life sciences, alongside their intricate structures, has led to the necessity for EU GMP Annex 11 regulations. EU GMP Annex 11 governs the integrity and security of electronic.