The Adobe Acrobat Sign Bio-Pharma settings page is available to the enterprise and business levels of service
The Bio-Pharma Settings page exposes the critical signature elements required for companies looking to comply with Title 21 CFR Part 11:
Before diving into settings configuration, admins should review the Analysis of Shared Responsibilities and the Handbook for 21 CFR Part 11 and EudraLex Annex 11 to fully understand the functionality of the Acrobat Sign product within the scope of obtaining a compliant signature in the healthcare and life science domain.
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.
The enforced identity authentication settings govern when the recipient is challenged to enter their authentication.
There are three options:
When Signing Reasons are 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:
If both options are enabled, then the pick-list will have a line item to allow the custom reason entry (as seen above)
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:
For Enforced identity authentication to work, the signer must be authenticating their identity with either:
The authentication method is defined on the Send Settings page in the Identity Authentication Methods section.
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
Identity Authentication for Internal Recipients
Access to the Bio-Pharma Settings page itself is enabled for all enterprise and business tier accounts.
All settings on the Bio-Pharma page can be enabled at the Account level by the Acrobat Sign Account Admin.
Group level settings are permitted and will override the Account level values.
To access the options, navigate to: Account Settings > Bio-Pharma Settings
If you still have questions you can contact support for assistance.