How Logilab SDMS Helps Laboratories Enable Eudralex Annex 11 Compliance - Part 1

How Logilab SDMS Helps Laboratories Enable Eudralex Annex 11 Compliance - Part 1

Compliance with Eudralex Annex 11 is essential for laboratories that rely on computerized systems within regulated environments. The regulation defines expectations for the use of electronic records, electronic signatures, and system controls to ensure data integrity, security, and reliability. Logilab SDMS supports laboratories in establishing a structured approach to scientific data management by providing controlled and compliant handling of electronic records in alignment with Annex 11 principles.

Inside this white paper, you will learn:

• Why Eudralex Annex 11 is important for laboratories using computerized systems
• The primary focus areas of Annex 11, including system features, SOPs, and validation
• How Annex 11 supports compliance, operational efficiency, and ease of use
• How Logilab SDMS provides a foundation for Annex 11 aligned laboratory data management