New Regulated Signing Controls Add Stronger Authentication, Audit Trails, and Recordkeeping for FDA-Regulated Organizations
PORTLAND, OR – November 5, 2026 – SignWell, the eSignature platform trusted by 80,000 businesses, today announced support for 21 CFR Part 11. SignWell now provides healthcare and life sciences organizations with a comprehensive compliance offering for electronic signatures, including FDA-regulated records and workflows.
For organizations in pharmaceuticals, biotechnology, medical devices, healthcare, and other regulated industries, electronic signatures introduce additional requirements for signer identity, auditability, validation, and record retention. Unfortunately, far too many organizations are left choosing between basic electronic signature tools that do not meet those needs and enterprise platforms that can be incredibly expensive and difficult to manage. SignWell’s addition of 21 CFR Part 11 support gives FDA-regulated teams another option.
Expanding SignWell’s health sector compliance offering with 21 CFR Part 11 support adds the authentication, auditability, and record controls healthcare and life sciences organizations need for regulated electronic signature workflows. SignWell also includes comprehensive HIPAA support, signed Business Associate Agreements (BAAs), SOC 2 Type II controls, and secure audit trails to meet all regulatory and compliance needs of health and life sciences organizations in one, simple solution. The new capability is now available for SignWell Business plan users.“Compliance should not be treated as an expensive add-on when it comes to electronic signature solutions,” said Sam Wehbe, CEO of SignWell. “We’ve fully embedded all necessary functionality to support the compliance needs of health and life sciences companies when it comes to HIPAA controls, signed BAAs, and now 21 CFR Part 11 support. We understand the economic constraints many organizations in regulated industries operate under and are dedicated to delivering comprehensive solutions to streamline the process.”
Learn more at: https://www.signwell.com/industries/healthcare/
About SignWell
SignWell is an eSignature platform trusted by 80,000 businesses worldwide for more than 17 million signed documents. Built for mid-market teams and API-driven platforms that need powerful document workflows, the SignWell platform provides enterprise-grade compliance, automation, and integration depth without the complexity or cost of legacy tools. Backed by SOC 2 Type II-certified security, HIPAA support, and audit-ready tracking, it offers reliable workflow automation, conditional logic, and embedded signing with flat pricing and no long-term contracts. Learn more at www.signwell.com.
