This white paper outlines how the Spotfire product family supports compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. It explains how Spotfire enables secure user authentication, audit trails, data integrity, and controlled access to analytical content. The document details technical controls such as role-based permissions, version control, and logging that support regulated environments. Designed for life sciences and regulated manufacturing organizations, the paper demonstrates how Spotfire analytics can be deployed while maintaining compliance, traceability, and validation requirements.

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