21 CFR Part 11: FDA approved electronic signatures with Comalatech and inWebo
To market products in the United States, all companies in the pharmaceutical, cosmetics and food industries must meet the requirements of the Food and Drug Administration (FDA) 21 CFR Part 11, a regulation that establishes the compliance requirements for electronic records and signatures.
FDA 21 CFR Part 11 regulation
Requirements of FDA 21 CFR Part 11
The purpose of FDA 21 CFR Part 11 is to ensure that electronic records and electronic signatures can be trusted as much as paper records and ink signatures. With this regulation, the Food and Drug Administration (FDA) aims to prevent the release of non-compliant products which could have serious health consequences. To achieve this, it requires companies to implement, test and certify controls to ensure the authenticity, reliability and validity of software and systems that process their digital data and electronic signatures.
Multifactor authentication to prove the validity of a signature
FDA CFR 21 Part 11, Subpart C, requires that electronic signatures be unique to one individual. One way to ensure this is to require Multifactor Authentication (MFA) to confirm the validity of a signature.
Industries impacted by 21 CFR Part 11
The traceability requirement of 21 CFR Part 11 was first mainly intended for the pharmaceutical industry because of the high health and medical stakes involved. However, it quickly spread to other industries such as food and cosmetics.
Comalatech Uses inWebo's MFA Technology for FDA-Regulated Electronic Signature Compliance
To help teams meet FDA requirements and manage their e-signature tool within Atlassian Confluence, Comalatech integrated inWebo’s patented multifactor authentication (MFA) technology earlier this year. inWebo MFA provides a simple and highly secure e-signature experience for all Comalatech users.