DocuSign’s Part 11 Module for Life Sciences enables compliant, digital approvals aligned with FDA and global standards like 21 CFR Part 11, HIPAA, and Annex 11. It ensures audit-ready, traceable transactions and integrates easily into existing systems. The DocuSign Validator automates compliance testing and documentation, saving time, reducing costs, and minimizing manual work. Detailed reports support audits with test data and screenshots. With a turnkey setup, teams can quickly activate validation to streamline regulatory compliance and focus on accelerating product development and market delivery.

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