Teams working within FDA* regulated environments understand the need to ensure their Confluence documentation is compliant. For many, it is important that Confluence documents have an e-signature solution that meets the requirements of the FDA CFR 21 Part 11 regulation. To help teams meet these requirements, earlier this year Comalatech integrated inWebo’s patented Multifactor Authentication (MFA) technology into the Comala Document Management app to provide a simple-yet-secure e-signature experience. 

Authenticate e-signatures easily
FDA CFR 21 Part 11, Subpart C requires that electronic signatures be unique to one individual. One way to ensure this is to require MFA to confirm the validity of a signature. 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 (Deviceless MFA Technology). 

Independently verify every approval signature 
Approval workflows built in Comala Document Management can be applied at the page, space or enterprise level. The ability to define exactly which pages require an e-signature approval, and assign it to the individual(s) through workflow builder makes it easier for teams to verify e-signatures across all Confluence documentation. Regardless of the number of documents, or the amount of individuals that must provide an e-signature, Document Management and inWebo scale to ensure every document that needs an e-signature is signed with MFA.

Maximize loss prevention safeguards
Document Management combined with inWebo’s SaaS based technology removes the need for additional token generating equipment. The less equipment relied on for security, the more protected a team’s Confluence documents are from cyberthreats because there is no extra physical device (hardware token) to lose or steal. Furthermore, by limiting token generation to PCs (which are generally password protected by the owner), this helps to meet the FDA’s CFR 21’s safeguard requirements to prevent unauthorized use of passwords or identification codes.

A powerful combination
Comalatech has been a vendor in the Atlassian marketplace for over ten years and is consistently rated as top vendor, and inWebo is a leader in the cybersecurity industry protecting the access of more than 500 companies worldwide. Combined, you can trust that your Confluence documents have a secure and credible e-signature solution that helps teams stay compliant in a FDA regulated environment. 

Try Comala Document Management, featuring inWebo’s MFA, free for a 30 day trial. Visit the Atlassian Marketplace to get started.

*US Department of Health and Human Services. (2020). U.S. Food and Drug Administration: CFR – Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11