CFR Part 11 compliance helps companies in industries such as pharmaceutical, biotechnology, healthcare, clinical research, medical devices, and financial services keep electronic records compliant with US federal regulations.

PandaDoc, an all-in-one software for document automation and e-signatures, today announced the availability of 21 CFR Part 11–ready workspaces designed to help organizations in regulated industries execute electronic signatures as part of validated, compliant processes. With this launch, customers operating in FDA-regulated environments can now access signature manifestation (signer name, timestamp, and intent) and template-level identity verification, reducing manual effort while strengthening audit readiness.

“Companies working in regulated industries can now use PandaDoc to streamline their compliance with FDA regulations,” said Mikita Mikado, CEO of PandaDoc. “Our 21 CFR Part 11 solution pairs clear controls with PandaDoc’s intuitive interface so organizations can digitize approvals, simplify audit trails, and reduce manual work.”

What’s available at launch

• Dedicated CFR Part 11–ready workspaces with enforced access controls and permissions for regulated workflows.
• Signature manifestation showing signer name, timestamp, and signing intent.
• Template-level identity verification so admins can require dual-authentication on specific templates.

Who it’s for

Organizations that submit electronic records to the U.S. FDA, including pharmaceutical, biotechnology, medical device, clinical research, and healthcare entities, as well as global companies whose U.S. activities fall under 21 CFR Part 11.

“This release is focused on pragmatic compliance enablement — real controls, clear auditability signals, and a deployment approach that meets teams where they are,” said Mikado. “We’re pairing an accessible price point with white-glove configuration so companies can modernize paper-heavy processes without sacrificing control.”

To speak with a specialist and enable a CFR Part 11–ready workspace, contact PandaDoc today.

About PandaDoc

Founded in 2013, PandaDoc is a leading document automation software platform that empowers professional teams to simplify and automate the creation, management, and signing of critical business documents of every kind. By combining intuitive e-signature technology with robust analytics and collaboration tools, PandaDoc helps businesses increase efficiency, close deals faster, and create exceptional customer experiences.

Proudly remote-first, PandaDoc’s team of 700+ employees serves over 56,000 customers worldwide. Backed by prominent investors including OMERS Growth Equity, Microsoft’s M12, HubSpot, and Altos Ventures, PandaDoc is dedicated to delivering bold, transparent, and practical solutions to help businesses of every size operate and win.

For more information, please visit: www.PandaDoc.com

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PandaDoc's CFR Part 11 compliance helps companies in industries such as pharmaceutical, biotechnology, healthcare, clinical research, medical devices, and financial services keep electronic records compliant with US federal regulations.