SignWell has announced support for 21 CFR Part 11, expanding its electronic signature compliance capabilities for healthcare and life sciences organizations. The new offering helps businesses meet FDA regulatory requirements for electronic signatures, records and workflows, providing a more comprehensive solution for managing regulated documentation and compliance processes.
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.”
