21 CFR Part 11 compliance with electronic signatures | FDA - Zoho Sign

21 CFR Part 11- Overview

Available in Enterprise edition and will be enabled in your account on request


Zoho Sign now aids businesses and individuals operating in the Food and Drug Administration (FDA)-regulated industries, such as pharmaceutical, biotech, cosmetic, food and beverage, and others, to carry out paperwork in a manner compliant with their legal and regulatory obligations with regards to electronic signatures under the 21 CFR Part 11 regulation.

How Zoho Sign fits with 21 CFR Part 11

As per the FDA standards for 21 CFR Part 11 for electronic records and signatures, Zoho Sign is categorized as an open system, where certain security measures must be implemented to protect the records from being compromised by unauthorized users.

Zoho Sign will be useful for FDA-regulated organizations to ensure the authenticity and integrity of the records and the signatures end-to-end. It also automates the digital signature collection virtually across the globe. Zoho Sign offers the requisite industry-standard capabilities through administrative restrictions for 21 CFR Part 11 compliance.


Zoho Sign 21 CFR Part 11 Compliance Information

This section provides information about the various controls available in Zoho Sign for 21 CFR Part 11 compliance and customers' responsibilities. This is just Zoho Sign's portion of the technological solution for 21 CFR Part 11 compliance. Organizations should use the right mix of technology, policies, and procedures together to achieve full compliance of 21 CFR Part 11. The information presented herein should not be taken as legal advice. We strongly recommend that you seek legal advice on what you need to do to comply with the requirements of 21 CFR Part 11 for your organization.

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