Simplify 21 CFR Part 11 Compliance Documentation
Life sciences organizations have invested heavily in digital transformation, yet paper-intensive processes continue to undercut the promise of automation. From research labs to manufacturing floors, scanning documents and collecting handwritten signatures remain embedded in otherwise digital workflows—creating compliance risk, slowing cycle times, and limiting collaboration with CROs, customers, and suppliers.
The challenge? While Part 11 compliance is standard today, many solutions still rely on clunky, fragmented workflows that hinder collaboration. Today's fast-moving regulated environments require a more unified approach—a platform that supports regulatory integrity without sacrificing speed and uptime.
This ebook explores how the Docusign Intelligent Agreement Management (IAM) platform bridges that gap—enabling life sciences organizations to send, sign, and approve regulated documents from virtually anywhere without compromising compliance. Inside, you'll learn:
How Docusign's Life Sciences Module supports 21 CFR Part 11 and Annex 11 compliance with purpose-built controls, including signature-level credentialing, signing reasons, and multi-factor authentication
How Docusign operates as a compliant open system under Part 11, with encryption, tamper-proof audit trails, and ISO 27001:2013 certification
A detailed regulatory walkthrough mapping key Part 11 subsections to the technical controls Docusign provides
Guidance on validation strategies, including third-party validation packages and in-house approaches to streamline ongoing compliance
Stop letting paper processes hold back your digital transformation. Download the full ebook to see how leading life sciences organizations are achieving compliant, end-to-end digital agreement workflows.