Pharmaceutical organizations operating in the European Union must comply with EudraLex Annex 11 regulations, which govern computerized systems used in manufacturing and quality control processes. These rules require validated systems that ensure data integrity, strong security controls, and detailed documentation throughout the lifecycle of pharmaceutical data. The Kiteworks platform supports these requirements through a hardened virtual appliance architecture, DevSecOps validation processes, and layered security controls including embedded firewalls, zero-trust access policies, and comprehensive audit logging. Double encryption protects both files and storage systems while preserving data accessibility for long-term archival. Role-based access controls and multiple authentication methods

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