{"id":249184,"date":"2023-07-13T10:50:00","date_gmt":"2023-07-13T10:50:00","guid":{"rendered":"https:\/\/simplerqms.com\/?p=249184"},"modified":"2024-01-25T14:22:28","modified_gmt":"2024-01-25T14:22:28","slug":"eu-annex-11","status":"publish","type":"post","link":"https:\/\/simplerqms.com\/eu-annex-11\/","title":{"rendered":"Annex 11: Computerized Systems (What You Need to Know)"},"content":{"rendered":"\n
EU Annex 11 outlines requirements for using computerized systems in the Life Science industries operating within the European Union.<\/p>\n\n\n\n
It is a guidance document for interpreting the principles of good manufacturing practice (GMP) for medicinal products.<\/p>\n\n\n\n
In this article, we will cover the basics of EU Annex 11, who needs to comply with it, its parts, the requirements, and the differences between 21 CFR Part 11 and Annex 11. We will also discuss how the SimplerQMS eQMS software solution helps ensure compliance with EU Annex 11.<\/p>\n\n\n\n
EU Annex 11 was introduced in 2011 as an addition to EudraLex Volume 4 GMP guidelines due to the increased use and complexity of computerized systems employed in GMP-regulated processes.<\/p>\n\n\n\n
To help improve compliance with stringent GMP requirements and streamline their quality processes, Life Science companies are progressively adopting electronic Quality Management Systems (eQMS).<\/p>\n\n\n\n
SimplerQMS offers EU GMP Annex 11-compliant eQMS software tailored to the needs of Life Science companies. You can schedule a demo<\/a> to explore how SimplerQMS can benefit your company’s compliance and quality management efforts.<\/p>\n\n\n\n We will discuss the following topics in this article:<\/p>\n\n\n\n EU Annex 11 is a European Union (EU) guideline that outlines the requirements for computerized systems used to manufacture human and veterinary medicinal products.<\/p>\n\n\n\n It is part of the EudraLex Volume 4 GMP guidelines, which set out the requirements that manufacturers of medicinal products can follow to ensure the quality of their products.<\/p>\n\n\n\n The purpose of EU Annex 11 is to establish clear guidelines for using computerized systems in GMP-regulated activities, ensuring the reliability and security of electronic systems.<\/p>\n\n\n\n A computerized system is a combination of hardware and software components working together to accomplish a specific task, according to EU Annex 11.<\/p>\n\n\n\n It applies to all computerized systems used in GMP-regulated activities, including but not limited to:<\/p>\n\n\n\n EU Annex 11 requires all computerized systems to be validated and IT infrastructure to be qualified. This means verifying that a computerized system fulfills its intended purpose and operates as expected while ensuring that the IT infrastructure is capable of supporting the system’s intended functions.<\/p>\n\n\n\n\n
What Is EU Annex 11?<\/h2>\n\n\n\n
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