Validation of computer systems. EMA European Regulations. GMP Annex 11

The European regulatory context for the validation of computer systems in the field of Good Manufacturing Practices (GMP) is governed by Annex 11 of the GMP guides of the European Union. This annex establishes requirements for computerized systems used in the production and quality control of medicinal products (pharmaceutical sector). Its objective is to ensure that computer systems are validated to meet quality and security standards, in line with technological advances and regulatory expectations.

The current version of this document dates back to 2011 and was based on the GAMP guide and covers key aspects such as:

• validation
• data integrity
• security
• User Management
• backup

It is crucial to ensure that systems are reliable, data is accurate and protected from unauthorized alterations. The guide emphasizes the importance of documenting systems validation and maintenance processes to meet regulatory standards.

Conceptual document for the review of Annex 11

In November 2022, the EMA published a conceptual document (concept-paper) outlining the need to review Annex 11 of Europe’s GMP guidelines. This draft reflects the need to adapt to current technological and regulatory developments, including digital transformation, artificial intelligence and machine learning. The proposal seeks to align with modern guidelines such as the FDA’s Computerized Software Assurance (CSA) and GAMP5 in its second edition.

It proposes improvements in topics such as the validation of cloud service providers and the use of agile methods. The draft document of this new Annex 11 is scheduled to be made public at the end of 2024.