PandaDoc, a software provider specializing in document automation and e-signatures, has announced the availability of 21 CFR Part 11–ready workspaces. These new features are designed to assist organizations in regulated sectors with executing electronic signatures as part of validated, compliant processes.
With this launch, customers operating in FDA-regulated environments can now access enhanced signature manifestation capabilities, which include the signer’s name, timestamp, and intent. The solution also introduces template-level identity verification. These additions are intended to reduce manual effort for compliance and strengthen audit readiness for companies that need to keep electronic records compliant with US federal regulations.
Organizations submitting electronic records to the U.
S. FDA, such as those in pharmaceutical, biotechnology, medical device, clinical research, and healthcare, are the primary beneficiaries. This also extends to global companies whose U.
S. activities fall under 21 CFR Part 11.
Mikita Mikado, CEO of PandaDoc, stated, “Companies working in regulated industries can now use PandaDoc to streamline their compliance with FDA regulations. 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.”
Key features available at launch include dedicated CFR Part 11–ready workspaces with enforced access controls and permissions for regulated workflows. The signature manifestation feature provides critical details for audit trails, while template-level identity verification allows administrators to require dual-authentication on specific templates.
Mikado further commented, “This release is focused on pragmatic compliance enablement — real controls, clear auditability signals, and a deployment approach that meets teams where they are. We’re pairing an accessible price point with white-glove configuration so companies can modernize paper-heavy processes without sacrificing control.”
Founded in 2013, PandaDoc is a document automation software platform that enables professional teams to simplify the creation, management, and signing of business documents. The company serves over 56,000 customers worldwide with a team of more than 700 employees. PandaDoc is backed by investors including OMERS Growth Equity, Microsoft’s M12, HubSpot, and Altos Ventures.
