What is Annex 11?
Annex 11 is a supplement to the European Union’s good manufacturing practice (EU GMP) guidelines that address electronic systems used in regulated industries, including pharmaceutical, biotechnology, and medical device firms. It details how to use electronic records and signatures, as well as offers guidelines for data integrity, validation, security, audit trails, and training. The purpose of the annex is to ensure that electronic systems are reliable and secure and that they comply with regulatory requirements. Compliance with Annex 11 is necessary to guarantee product safety, efficacy, and quality. Noncompliance with Annex 11 may result in regulatory action like cautioning letters, fees, or even product recalls.