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.

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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.

“Integrated right into Confluence through the Comala Document Management app, teams can opt for inWebo’s MFA technology, which allows users to authenticate (proving their identity) with the highest level of security and without any equipment constraints. Document Management users who choose inWebo can execute authentication using either their computer, tablet, mobile phone, or even their browser.”

Comalatech

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Authenticate e-signatures easily

Confluence users can experience a simple, fast and, most of all, very secure authentication using either their computer, tablet, mobile phone, or even their browser ( Deviceless MFA technology). inWebo’s SaaS based technology removes the risk of loss or steal that you have with hardware tokens.

Go Passwordless to meet FDA compliance

inWebo's SaaS mode, combined with its Passwordless technology, allows you to meet FDA CFR 21 requirements and prevents unauthorized use of passwords or identification tokens.

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Independently verify every approval signature

Approval workflows built in Comala Document Management can be applied at the page, space or enterprise level. A feature that makes it easier for teams to verify electronic signatures across Confluence documentation.

Don't settle for just any MFA solution

Get in touch for a demo or to request a free trial of our multifactor authentication solution

Highest level of security on the market

inWebo MFA features the unique and patented technology of dynamic random keys. This ensures the highest level of security on the market. Solution certified by the French National Cybersecurity Agency (ANSSI).

Easy integration and deployment

Accessible in Saas, rich in connectors, API and SDK, a solution that adapts to your technical architecture, without imposing new constraints. Deploy MFA quickly and on a very large scale, without human contact or logistics.

Passwordless and deviceless user experience

inWebo allows you to offer a simplified user experience, extended to all dimensions of authentication, from enrolment to login thanks to its universal, passwordless and deviceless tokens.

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