21 CFR 11 Compliant e-Signatures on Confluence Cloud - Requirements Checklist and App Comparison

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What is an “Electronic Signature”?

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. (21 CFR 11.3)

In other words, to Electronically Sign a document means to execute of a series of actions that are secret and unique to each user. Excluding biometric methods, this is typically achieved with a unique ID and a “secret” (e.g. username and password or token.)

Is it ok to use the Confluence password as secret?

Not ideal, especially if the accounts are managed. An admin could potentially impersonate another user and apply electronic signatures on its behalf. In addition, Atlassian accounts password need to be set to have an expiry date (not a default option).

e-Signature apps in Confluence

Confluence itself has no such feature as electronic signature. In order for you to sign your documents in Confluence, you will require a Confluence app to do so. With a long list of e-signature apps available on Atlassian Marketplace, we provide you with a list of requirements you should look for when choosing one that is compliant with 21 CFR 11. We also provide a comparison of 18 e-signature apps on Confluence Cloud.

What should I check when looking for an App with compliant e-signatures?

When you and your team are choosing an e-signature app, you can use this checklist below at the product demos to ensure your chosen app is compliant. All the listed questions must have a positive response for the e-signature app to demonstrate that it is 21 CFR 11 compliant.

Comparison of e-Signature Apps on Confluence Cloud

This is a comparison of the 18 most popular e-signature apps on the Atlassian Marketplace and there may be others available. Please note that for some Apps the assessment was made using the App manual.

To learn more about the 21 CFR 11 requirements and compliant e-signatures, please check out our recent blog post about it here.

To check out the compliant document management app from SoftComply, feel free to book a live demo call with our team. Or try it out for free for 30 days on Confluence Cloud.

This article was originally published on SoftComply blog.