This tutorial will look at Bio-Pharma settings in Adobe Sign account settings, which allow you to configure Adobe Sign to meet FDA 21 CFR Part 11 requirements. These settings enforce identity at signing time, they require a reason for signing and they timestamp the signature block. So, to use these settings, log into your account and you must have account administrator privileges. Then, click on Account and either type bio in the Search field to quickly find the settings, or you can just scroll down and find them under Account Settings.

So, first up, we have Enforce identity authentication. And this is the center of the enforcement of the requirement. Checking this box will force signers to authenticate when they open a document when they’re ready to sign and after they sign. And this works only with phone and/or Adobe Sign authentication turned on. This is detailed here in this Help pop up. And we’ll learn more about this when we walk through our example. But clicking on this link will take us over to the relevant Send Settings. And here you can see that we have both of these options checked. And in this case, a phone authentication is selected as the default option. So next, we have Signing Reasons. And we can turn on the option for signers to provide a reason for signing for both e-signature workflows and cloud-based digital signature workflows. With one or both of these options turned on, further options are activated. We can make it mandatory rather than optional that signers provide a Signing Reason. So, if this is selected, signing can’t proceed until the signer chooses a reason. And we can also allow signers to provide their own custom Signing Reason beyond the list of saved reasons at the bottom of the screen. These are the Signing Reason options available to the signer and these are reasons that I’ve already added. To add a new reason, just click on the plus icon.

And if, for example, I want to include author as a Signing Reason, we just enter the relevant text and then click Save when done. Again, always remember to save your settings when you’re finished.

So, with those settings done, let’s see how it works. The signer will receive an email, click on the link to open it, and they’ll be immediately presented with the specified authentication method, in this case, phone. So, they’ll get a code send to their mobile and enter it here to verify.

Then, they’ll complete the document and when they attempt to sign, again, they’ll be presented with the authentication requirement.

With that completed successfully, they’ll proceed to add their signature to the document.

And when they click Apply, they’ll get the Signing Reason requirement. And as in the settings that I showed earlier, they have the option to enter their own reason, or they can choose from the list. So, they enter a Signing Reason and then they can Click to Sign. At which point, they go through the verification process one last time. And with successful signing, a copy of the agreement is sent to all parties.