Configure bio-pharma settings

The Adobe Sign Bio-Pharma settings page is available to the enterprise and business levels of service

Overview

The Bio-Pharma Settings page exposes the critical signature elements required for companies looking to comply with Title 21 CFR Part 11:


How it's used

The Bio-Pharma Settings page can be configured at the account or group level.

Once the settings are configured, all subsequent agreements will enforce the defined signature requirements.

Senders do not need to alter their process, as the settings come into effect during the signature process.


Enforced identity authentication

The enforced identity authentication settings govern when the recipient is challenged to enter their authentication.

There are three options:

  • Challenge when the agreement is opened - Upon opening the agreement, the recipient is challenged to authenticate (before the content is exposed)
  • Challenge for each signature - Upon clicking a signature field, the recipient is challenged to authenticate
  • Challenge when the agreement is finalized - Upon clicking the Click to Sign button, the recipient is challenged to authenticate

 

Enforced authentication requires one of two authentication methods:

  • Phone authentication - An SMS based text that provides a five-digit code which the signer must enter before affixing the signature
  • Adobe Sign authentication - A request to provide the signer's Adobe Sign password
    • Adobe Sign authentication must be enabled by the Support team or your CSM
Phone Auth


Reasons for signing

When Reason for signing is enabled, the signer is asked to provide a reason for applying their signature immediately after they type, draw or upload their signature image.

The signature is displayed in a new panel with either:

  • An open text field that can accept a custom reason from the signer
  • A drop-down list of acceptable reasons (as defined in Adobe Sign)

Note:

If both options are enabled, then the pick-list will have a line item to allow the custom reason entry (as seen above)


Configuration options

Individual configuration options for the two feature sets are explained in detail on their own respective pages:

 

However, there are some general recommendations for customers looking to comply with Title 21 CFR Part 11:

 

Prerequisites

For Enforced identity authentication to work, the signer must be authenticating their identity with either:

  • Phone authentication (SMS)  
  • Adobe Sign authentication

The authentication method is defined on the Send Settings page in the Identity Authentication Methods section.

 

General recommendations

With the above prerequisites in mind, the below general Identity Authentication Methods are recommended.

These settings ensure that Enforced identity authentication is applied to all transactions, and that the sending agents cannot accidentally disable the feature.

    

Identity Authentication Methods

  • Require senders to specify one of the enabled authentication methods for recipients: Enable
    • You want to require recipient authentication
  • Enable the following identity authentication methods for recipients: Phone Authentication
    • Most external recipients can be expected to have a phone that supports SMS authentication
    • It's generally unknown if the recipient has an Adobe Sign account to authenticate with.
  • By default, use the following authentication method: Phone authentication
    • For the reasons above
  • Allow senders to change the default authentication method: Disable
    • This ensures a consistent experience for your signers

 

Identity Authentication for Internal Recipients

  • Enable different identity authentication methods for internal recipients: Enable (probably)
    • Enable this if your internal signers have Adobe Sign accounts
  • Enable the following identity authentication methods for recipients: Adobe Sign authentication
    • Authenticating with the Adobe Sign log in is less friction than the SMS solution
  • By default, use the following method: Adobe Sign authentication
  • Allow senders to change the default authentication method: Disable
Identity Authentication


How to enable or disable

Access to the Bio-Pharma Settings page itself is enabled for all enterprise and business level accounts.

 

All settings on the Bio-Pharma page can be enabled at the Account level by the Adobe Sign Account Admin.

Group level settings are permitted, and will over-ride the Account level values. 

 

To access the options, navigate to: Account > Account Settings > Bio-Pharma Settings

Bio-pharma page


Contact Support

If you still have questions you can contact support by taking the following steps:

  • Log in to your Adobe Sign account with your account admin email
  • Open the support page by clicking the (?) in the upper-right corner of Adobe Sign
  • Choose Contact Support
Contact Support

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