How Logilab SDMS Helps Laboratories Enable Eudralex Annex 11 Compliance - Part 3

How Logilab SDMS Helps Laboratories Enable Eudralex Annex 11 Compliance - Part 3

Eudralex Annex 11 places strong emphasis on validation, data integrity, security, and lifecycle control of computerized systems used in GMP regulated activities. Laboratories must demonstrate that their systems are fit for intended use, operate in a validated state, and support reliable, traceable, and secure management of electronic data. This white paper explains how Logilab SDMS addresses these expectations by embedding compliance oriented functionalities into scientific data capture, management, and long term archival processes.

Inside this white paper, you will learn:

• How Logilab SDMS supports validation, risk management, and system lifecycle control
• How audit trails, electronic signatures, security, data integrity, and change control are enabled within Logilab SDMS
• How Logilab SDMS supports business continuity, archiving, and long-term data retention