Life Sciences Compliance

Life Sciences compliance

Comply with FDA 21 CFR Part 11, the globally-accepted regulation for electronic records and signatures in the Bio-Pharmaceutical industry. Today CFR21 compliance is only possible using digital signatures. This release expands your options by enabling CFR21-11 compliance using:

• Enforced identity authentication with e-signatures, requiring discrete authentication each time a signature is applied:

• Reasons for signing, to include custom input or selection from a predefined pick-list:

• Enforce Local Timestamp – Show the secure signing time as a visual component of the signature block, using the local time zone offset. The time reference is saved to the document and logged in the audit trail.

SAFE-BioPharma® certified

The SAFE-BioPharma Association is a digital identity and digital signature standard for the global pharmaceutical, biotech and healthcare industries. Adobe Sign is a certified product meeting all the SAFE-BioPharma Product and Services Certification requirements. This solution also ensures compliance with FDA 21 CFR Part 11 using digital signatures when using authentication based on certificates issued by providers like TransSped.

Forms

Online payments

Easily and securely collect payments – such as contract fees, donations, and online orders – while recipients fill and sign forms. Requires a Braintree merchant account.

Available for customer accounts in the NA, EU and AU datacenters.

Fill only with Fill & Sign

Do more with Fill & Sign. In addition to filling and signing documents sent to you by others, now, you can simply fill in a form without adding a signature.

Cloud Signature Advances

Cloud signature provider preselection

Ensure consistency and compliance with corporate standards by preselecting one or more cloud-based Digital ID providers through the Account:Admin menu.

Group control over digital signatures

Group administrators can now control digital signature preferences for their specific business processes. Choose to show or hide digital signature form fields in the authoring experience, require that signers add a reason for signing, and more.

BankID signing in Sweden

Easily get signatures from customers and partners in Sweden. Over 6.5M people in Sweden can sign securely using the digital identity given to them by their bank. No enrollment or downloads required.

More digital ID provider choices

In the March and April timeframe, digital IDs from several previously announced partners will become available.

Adobe Sign authentication

Use your Adobe Sign password as second factor authentication. Perfect for internal signers that have an Adobe Sign account.

Experience Innovation

OneDrive integration

Get files from your Microsoft OneDrive storage. Senders can upload files when sending for signature. Signers can access OneDrive to upload images to be displayed in the document such as pictures, stamps or licenses.

Adaptive experiences

Adobe Sign continues to improve experiences for senders who use different screen sizes. In this release, the Home and Manage screens are optimized to reflow gracefully on screens of any size.

Expanded email customization

Expand your email customization with two new templates. Now, you can get full control over the email templates used to send reminders to people who haven't signed, or cancel a request for signatures. This is in addition to existing customization options for requesting and confirming signatures. Customization provided through Adobe professional services.

Feature Availability by Adobe Sign Plan

Resolved Issues

Required mobile signature

Preconfigure signature settings to mandate handwritten signatures on mobile devices. Signers get a text message sent to their mobile device so they can sign with their finger or a stylus.

Resolved Issues

Experience Innovation

Do more with workflow automation

Enhance business processes created with Adobe Sign’s Workflow Designer. The new Custom Workflow send experience improves the sending experience with a modern reflowable design that aligns with the Send experience. 

Read more about the Workflow Designer improvements >

Note there are differences from the Send experience because custom workflow allows inserting Instructions on how to configure the Send experience.  The new Workflow Send places these instructions at the top of the page as opposed to the classic experience where they were adjacent to the send parameters.

Additionally, once the new interface is enabled, these new features are available through the workflow designer:

• Use Library Templates that require signers to use Digital Signatures
• Configure recipients to authenticate via phone-based PIN
• Configure recipient groups to be defined on the Send page
• Attach files from any enabled source on the Send page

Sign simple forms with a digital ID

Use the Fill & Sign tool to sign documents or forms with a cloud-based digital signature, regardless of the document format.  Just upload an agreement and place the signature.  

Of course, all of the previous capabilities of the Fill & Sign product continue to be available.   It couldn’t be easier!

Learn more about Fill & Sign >

SMS Verification Customization

Customize your SMS verification process with your company name to ensure your recipients know that the PIN number is coming from your company.

Read more about this new feature >

Expanded Compliance

GDPR

Customer account admins can fully comply with the European Union General Data Protection Regulation(GDPR) through direct control of the information collected from signers. Privacy Admins have the authority to remove employee user information from the system, as well as deleting agreements from signers that are no longer needed for business operations.

The GDPR compliance overview can be found here >

Three tools are available to support GDPR:

• User Logs - Users are allowed to know what personal information Adobe Sign collects

• Agreement Deletion - Privacy administrators have the authority to search for a recipient's email, review any agreements found, and delete any that are no longer of value

• User Deletion - Privacy administrators have the authority to fully delete any user in their account

BioPharma enhancements

Allow for 21 CFR Part 11 compliance with any custom workflow in your account. 

The Workflow Designer now support digital signatures.

When Enforced Identity Authentication is enabled, the recipient is additionally required to authenticate when they click the Click to Sign button.  

• This final authentication can be removed by request to your Success Manager

By default, the Adobe Sign authentication method inserts the email address of the recipient into the authentication panel. 

• Your Success Manager can configure the default action to leave the email field empty 

The BioPharma overview can be found here >

FedRAMP Tailored

Adobe Sign fully complies with the FedRAMP Tailored requirements for all users, all service levels.

Cloud Signature Advances

Enhanced Cloud Signature controls

Adding granularity to the cloud signature pre-selection functionality, Admins gain control over which digital ID providers the signer sees based on whether they're internal or external to their Adobe Sign organization.

Customers that have a relationship with a restricted provider (eg: BankID) need to deliver their Account ID to that provider so they can enable access to the IdP. Your Account ID can be found just under the options for external signers.

Learn more about ID provider selection here >

RSA-PSS support

Support more secure signature algorithm. Complies with Germany-specific requirements for Qualified Electronic Signatures.

Cloud Signature Advances

Integrate with v6 REST APIs and Webhooks

Integrate Adobe Sign faster and gain new efficiencies with next-generation API tools, including an all-new Webhooks admin experience to create push notifications that can be used to update dashboards and trigger next-step processes.

Adobe Sign for Microsoft Dynamics CRM v7

Equip your sales teams to close deals faster with a completely redesigned user experience plus customer contact details from LinkedIn. And, automate your quote to cash process completely by embedding Adobe Sign into Microsoft Dynamics workflows.

All guides are listed on the Dynamics integration page >

Feature Availability by Adobe Sign Plan

Resolved Issues

User Experience Changes

GDPR Cookie Management

GDPR rules require that users from the European Union grant permission before saving any cookies that aren't strictly necessary for the page to operate.

EU users that operate under the free or individual service level must agree to this stipulation to continue to use the Adobe Sign service.

Cookie placement only needs to be agreed to once (per device), and then users are not prompted to accept again.

Customers under a team, business, or enterprise service level will have an account administrator accept the cookie placement for the whole of their account. Discrete users will only be prompted to accept the cookie placement if they access Adobe Sign before their admin does.

Signers from EU based IP ranges will also be required to accept the cookie placement before they can open their agreements.

Improved interface for the Custom Workflow Designer

Enterprise level customers that use the Custom Workflow designer will have the improved designer interface enabled.

The improved interface will become the only option in the December release, and admins are encouraged to familiarize themselves and their user base with the new functionality.

Customers that still need time to prepare their user base may revert their interface to the legacy experience until the December release by:

• Log in as an account administrator
• Navigate to Account > Account settings > Send Settings > Custom Workflow Send
• Uncheck the Enable new Custom Workflow send experience checkbox
  
• Click Save

Improved accessibility for visually impaired signers

Adobe Sign's commitment to improving accessibility takes a significant step forward in this release.

The page layout for screen readers has been optimized by removing screen reader clutter, identifying the user controls immediately, and the ability to get directly to the agreement without having to download the PDF. Screen readers can now read the document directly from the browser.

Default full-screen mode for Adobe Sign UI

In order to improve the experience on smaller devices and provide a better reading experience on the desktop, the Adobe Sign March release introduced a more flexible Sign UX based on the width of the browser. 

This was initially enabled selectively for enterprise accounts and generally for all individual and team accounts. 

In July this became the default configuration. All new users were able to see the web UI adapted to the width of the page and stack components instead of shrinking them to fit a narrow width. Existing users retained the option to revert back to the legacy experience.

With the September release, all users have been moved to the new reflowable experience, and the UI controls to revert to the legacy interface have been removed.

Experience Innovation

Populate Widget fields via URL parameters

Improve Widget efficiency by pre-populating field values with data from the widget URL. Eliminate the need to manage multiple widgets for near-identical forms.  Give signers a better experience by pre-populating fields they are not responsible for.  Give customers a way to author one widget but still segment/route responses to the appropriate stake holders or data analysts.

Click here for more details>

HIPAA Settings for Document Cloud clients

Users that interact with Adobe Sign through the Document Cloud interface, and that require HIPAA compliance, will want to enable the HIPAA compliance checkbox.

• Log in to Adobe Sign directly as an Adobe Sign account administrator
• Navigate to Account > Account Settings > HIPAA Settings 
• Check the box next to My Organization requires HIPAA compliance
• Click Save

This setting suppresses notifications through the Document Cloud interface.

Customers that log in to Adobe Sign directly do not need to enable this setting.

Users that interact with Adobe Sign through the Document Cloud interface, and that require HIPAA compliance, will want to enable the HIPAA compliance checkbox.

• Log in to Adobe Sign directly as an Adobe Sign account administrator
• Navigate to Account > Account Settings > HIPAA Settings 
• Check the box next to My Organization requires HIPAA compliance
• Click Save

This setting suppresses notifications through the Document Cloud interface.

Customers that log in to Adobe Sign directly do not need to enable this setting.

Expanded options for recipient reminders

Get more granularity when configuring signature reminder notifications. In addition to either daily or weekly reminders, you can configure reminders to be every other day, every workday, every third day, and every fifth day!

Click here for more information on reminders>

Feature Availability by Adobe Sign Plan

Resolved Issues

Trusted & Secure Industry Leading Solution

Verify signer identity with Government ID Authentication

The next step forward in recipient verification, Government ID authentication uses a government-issued document (passport/driver’s license/national ID) in combination with a real-time image of the recipient to provide a strong authentication of the recipient.

Thousands of global ID document types can be authenticated in real time by using dozens of AI-powered automated authentication techniques, such as document structure evaluation, BIO-MRZ comparison, etc.

Sophisticated face comparison algorithms are used to automatically compare the portrait extracted from the ID document with a recipient’s selfie; affirming that the recipient submitting the ID document is its rightful owner.

(Controlled release - Contact your success manager for access)

OAuth support for CSC partners

Signers can access their TSP digital signature with third-party credentials (Google, Facebook, etc.) via OAuth authentication service, eliminating the need to manually log in to the TSP with a username and password each time. 

Improved Audit Reports

Adobe Sign is creating a new official audit report that will only be created at the completion of a signature workflow. “Interim Audit Reports” will be available prior to the official “Final” report.  This new report will be rolled out gradually to the lower tier customers with this release and to all enterprise and global customers early in 2019.

Included in this change, the time stamp for all events will be set to to a YYYY-MM-DD format with a GMT time zone.

Improved User Experience

Intelligent signature placement in Custom Workflows

Agreements sent using custom workflows will now be able to use a single existing document template and workflow definition to skip optional signatures and fields on the agreement.

For example, a library template created for two external signers, and one internal counter-signer can now be sent to just one external signer. The workflow will skip over the fields defined for the second signer, ensuring the counter-signer applies their information to the correct field spaces.

Integrations

Send for Signature via Dropbox

Dropbox is launching a new "file actions" tool to their web-based experience where users can select individual files via the familiar Dropbox interface and with the new File Actions tool, send the selected file (Word Doc or PDF) for signature via Adobe Sign. An Adobe ID is required.

• FAQ page >
• User Guide >

Microsoft Dynamics 365 for Talent

Adobe Sign's integration with MS Dynamics 365 is expanding to Dynamics 365 for Talent, so HR and hiring managers can bring e-signatures to offer letters delivered via Dynamics. 

ServiceNow for HR

Adobe Sign seamlessly integrates with HR Service Delivery applications and can be used to add trusted, legally binding e-signature features to any document.

Workplace by Facebook

Adobe Sign is integrating with Workplace by Facebook, creating the ability for joint customers to seamlessly engage in an electronic signature workflow right from within the Workplace environment. Available in early 2019.

Resolved Issues