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Configure bio-pharma settings

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Adobe Acrobat Sign Guide

What's New

  1. Pre-Release Notes
  2. Release Notes
  3. Important Notifications

Get Started

  1. Quick start guide for administrators
  2. Quick start guide for users
  3. For Developers
  4. Video tutorial library
  5. FAQ

Administer

  1. Admin Console Overview
  2. User Management
    1. Adding users
      1. Add a User
      2. Add Users in Bulk
      3. Add Users from your Directory
      4. Add Users from MS Azure Active Directory
    2. Create function-focused users
      1. Technical accounts - API driven
      2. Service accounts - Manually driven
    3. Check for users with provisioning errors
    4. Change Name/Email Address
    5. Edit a user's group membership
    6. Edit a user's group membership through the group interface
    7. Promote a user to an admin role
    8. User Identity Types and SSO
    9. Switch User Identity
    10. Authenticate Users with MS Azure
    11. Authenticate Users with Google Federation
    12. Product Profiles
    13. Login Experience 
  3. Account/Group Settings
    1. Settings Overview
    2. Global Settings
      1. Account tier and ID
      2. New Recipient Experience
      3. Self Signing Workflows
      4. Send in Bulk
      5. Web Forms
      6. Custom Send Workflows
      7. Power Automate Workflows
      8. Library Documents
      9. Collect form data with agreements
      10. Limited Document Visibility
      11. Attach a PDF copy of the signed agreement 
      12. Include a link in the email
      13. Include an image in the email
      14. Files attached to email will be named as
      15. Attach audit reports to documents
      16. Merge multiple documents into one
      17. Download individual documents
      18. Upload a signed document
      19. Delegation for users in my account
      20. Allow external recipients to delegate
      21. Authority to sign
      22. Authority to send
      23. Power to add Electronic Seals
      24. Set a default time zone
      25. Set a default date format
      26. Users in Multiple Groups (UMG)
        1. Upgrade to use UMG
      27. Group Administrator Permissions
      28. Replace recipient
      29. Audit Report
        1. Overview
        2. Allow unauthenticated access on the transaction verification page
        3. Include reminders
        4. Include view events
        5. Include agreement page/attachment count
      30. Transaction Footer
      31. In Product Messaging and Guidance
      32. Accessible PDFs
      33. New authoring experience
      34. Healthcare customer
    3. Account Setup
      1. Add logo
      2. Customize company Hostname/URL    
      3. Add company name
      4. Post agreement URL redirect
    4. Signature Preferences
      1. Well formatted signatures
      2. Allow recipients to sign by
      3. Signers can change their name
      4. Allow recipients to use their saved signature
      5. Custom Terms of Use and Consumer Disclosure
      6. Navigate recipients through form fields
      7. Restart agreement workflow
      8. Decline to sign
      9. Allow Stamps workflows
      10. Require signers to provide their Title or Company
      11. Allow signers to print and place a written signature
      12. Show messages when e-signing
      13. Require signers to use a mobile device to create their signature
      14. Request IP address from signers
      15. Exclude company name and title from participation stamps
    5. Digital Signatures
      1. Overview
      2. Download and sign with Acrobat
      3. Sign with Cloud Signatures
      4. Include metadata for Identity Providers
      5. Restricted Cloud Signatures Providers
    6. Electronic Seals
    7. Digital Identity
      1. Digital Identity Gateway
      2. Identity Check policy
    8. Report Settings
      1. New report experience
      2. Classic report settings
    9. Security Settings
      1. Single Sign-on settings
      2. Remember-me settings
      3. Login password policy
      4. Login password strength
      5. Web session duration
      6. PDF encryption type
      7. API
      8. User and group info access
      9. Allowed IP Ranges
      10. Account Sharing
      11. Account sharing permissions
      12. Agreement sharing controls
      13. Signer identity verification
      14. Agreement signing password
      15. Document password strength
      16. Block signers by Geolocation
      17. Phone Authentication
      18. Knowledge-Based Authentication (KBA)
      19. Allow page extraction
      20. Document link expiration
      21. Upload a client certificate for webhooks/callbacks
      22. Timestamp
    10. Send settings
      1. Show Send page after login
      2. Require recipient name when sending
      3. Lock name values for known users
      4. Allowed recipient roles
      5. Allow e-Witnesses
      6. Recipient groups
      7. CCs
      8. Recipient Agreement Access
      9. Required fields
      10. Attaching documents
      11. Field flattening
      12. Modify Agreements
      13. Agreement name
      14. Languages
      15. Private messages
      16. Allowed signature types
      17. Reminders
      18. Signed document password protection
      19. Send Agreement Notification through
      20. Signer identification options
        1. Overview
        2. Signing password
        3. One-Time Password via Email
        4. Acrobat Sign authentication
        5. Phone authentication
        6. Cloud-based digital signature
        7. Knowledge-based authentication
        8. Government ID
        9. Signer Identity reports
      21. Content Protection
      22. Enable Notarize transactions
      23. Document Expiration
      24. Preview, position signatures, and add fields
      25. Signing order
      26. Liquid mode
      27. Custom workflow controls
      28. Upload options for the e-sign page
      29. Post-sign confirmation URL redirect
    11. Message Templates
    12. Bio-Pharma Settings
      1. Overview
      2. Enforce identity authentication
      3. Signing reasons
    13. Workflow Integration
    14. Notarization Settings
    15. Payments Integration
    16. Signer Messaging
    17. SAML Settings
      1. SAML Configuration
      2. Install Microsoft Active Directory Federation Service
      3. Install Okta
      4. Install OneLogin
      5. Install Oracle Identity Federation
    18. Data Governance
    19. Time Stamp Settings
    20. External Archive
    21. Account Languages
    22. Email Settings
      1. Email header/footer images
      2. Permit individual user email footers
      3. Customize the Signature Requested email
      4. Customize the To and CC fields
      5. Enable Linkless Notifications
      6. Customize email templates
    23. Migrating from echosign.com to adobesign.com
    24. Configure Options for Recipients
  4. Guidance for regulatory requirements
    1. Accessibility
      1. Accessibility Compliance
      2. Create accessible forms with Acrobat desktop
      3. Create accessible AcroForms
    2. HIPAA
    3. GDPR
      1. GDPR Overview
      2. Redact a user
      3. Redact a user's agreements    
    4. 21 CFR part 11 and EudraLex Annex 11
      1. 21 CRF part 11 validation pack
      2. 21 CFR and EudraLex Annex 11 handbook
      3. Analysis of shared responsibilities
    5. Healthcare customers
    6. IVES support
    7. "Vaulting" agreements
    8. EU/UK considerations
      1. EU/UK Cross-border transactions and eIDAS
      2. HMLR requirements for deeds signed electronically
      3. The impact of Brexit on e-signature laws in the UK
  5. Download Agreements in Bulk
  6. Claim your domain 
  7. Report Abuse links

Send, Sign, and Manage Agreements

  1. Recipient Options
    1. Cancel an email reminder
    2. Options on the e-signing page
      1. Overview of the e-sign page
      2. Open to read the agreement without fields
      3. Decline to sign an agreement
      4. Delegate signing authority
      5. Restart the agreement
      6. Download a PDF of the agreement
      7. View the agreement history
      8. View the agreement messages
      9. Convert from an electronic to a written signature
      10. Convert from a written to an electronic signature 
      11. Navigate the form fields
      12. Clear the data from the form fields
      13. E-sign page magnification and navigation
      14. Change the language used in the agreement tools and information
      15. Review the Legal Notices
      16. Adjust Acrobat Sign Cookie Preferences
  2. Send Agreements  
    1. Send page overview
    2. Send an agreement only to yourself
    3. Send an agreement to others
    4. Written Signatures
    5. Recipient signing order
    6. Send in Bulk
      1. Overview of the Send in Bulk feature
      2. Send in Bulk - Configure a parent template
      3. Send in Bulk - Configure the CSV file
      4. Cancel a Send in Bulk transaction
      5. Add reminders to Send in Bulk
      6. Reporting for Send in Bulk
  3. Authoring fields into documents
    1. In-app authoring environment
      1. Automatic field detection
      2. Drag and drop fields using the authoring environment
      3. Assign form fields to recipients
      4. The Prefill role
      5. Apply fields with a reusable field template
      6. Transfer fields to a new library template
      7. Updated authoring environment when sending agreements
    2. Create forms with text tags
    3. Create forms using Acrobat (AcroForms)
      1. AcroForm creation
      2. Creating accessible PDFs
    4. Fields
      1. Field types
        1. Common field types
        2. In-line Images
        3. Stamp Images
      2. Field content appearance
      3. Field validations
      4. Masked fields values
      5. Setting show/hide conditions
      6. Calculated fields 
    5. Authoring FAQ
  4. Sign Agreements
    1. Sign agreements sent to you
    2. Fill & Sign
    3. Self-signing
  5. Manage Agreements
    1. Manage page overview
    2. Delegate agreements
    3. Replace Recipients
    4. Limit Document Visibility 
    5. Cancel an Agreement 
    6. Create new reminders
    7. Review reminders
    8. Cancel a reminder
    9. Access Power Automate flows
    10. More Actions...
      1. How search works
      2. View an agreement
      3. Create a template from an agreement
      4. Hide/Unhide agreements from view
      5. Upload a signed agreement
      6. Modify a sent agreement's files and fields
      7. Edit a recipient's authentication method
      8. Add or modify an expiration date
      9. Add a Note to the agreement
      10. Share an individual agreement
      11. Unshare an agreement
      12. Download an individual agreement
      13. Download the individual files of an agreement
      14. Download the Audit Report of an agreement
      15. Download the field content of an agreement
  6. Audit Report
  7. Reporting and Data exports
    1. Overview
    2. Grant users access to reporting
    3. Report charts
      1. Create a new report
      2. Agreement Reports
      3. Transaction Reports
      4. Settings Activity Report
      5. Edit a report
    4. Data Exports 
      1. Create a new data export
      2. Web form data export
      3. Edit a data export
      4. Refresh the data export content
      5. Download the data export
    5. Rename a report/export
    6. Duplicate a report/export
    7. Schedule a report/export
    8. Delete a report/export
    9. Check Transaction Usage

Advanced Agreement Capabilities and Workflows

  1. Webforms 
    1. Create a web form
    2. Edit a web form
    3. Disable/Enable a web form
    4. Hide/Unhide a web form
    5. Find the URL or script code 
    6. Prefill web form fields with URL parameters
    7. Save a web form to complete later
    8. Resize a web form
  2. Reusable Templates (Library templates) 
    1. US Government forms in the Acrobat Sign library
    2. Create a library template
    3. Change a library template's name
    4. Change a library template's type
    5. Change a library template's permission level
    6. Copy, edit, and save a shared template
    7. Download the aggregate field data for a library template
  3. Transfer ownership of web forms and library templates
  4. Power Automate Workflows 
    1. Overview of the Power Automate integration and included entitlements
    2. Enable the Power Automate integration
    3. In-Context Actions on the Manage page
    4. Track Power Automate usage
    5. Create a new flow (Examples)
    6. Triggers used for flows
    7. Importing flows from outside Acrobat Sign
    8. Manage flows
    9. Edit flows
    10. Share flows
    11. Disable or Enable flows
    12. Delete flows
    13. Useful Templates
      1. Administrator only
        1. Save all completed documents to SharePoint
        2. Save all completed documents to OneDrive for Business
        3. Save all completed documents to Google Drive
        4. Save all completed documents to DropBox
        5. Save all completed documents to Box
      2. Agreement archival
        1. Save your completed documents to SharePoint
        2. Save your completed documents to One Drive for Business
        3. Save your completed documents to Google Drive
        4. Save your completed documents to DropBox
        5. Save your completed documents to Box
      3. Webform agreement archival
        1. Save completed web form documents to SharePoint Library
        2. Save completed web form documents to OneDrive for Business
        3. Save completed   documents to Google Drive
        4. Save completed web form documents to Box
      4. Agreement data extraction
        1. Extract form field data from your signed document and update Excel sheet
      5. Agreement notifications
        1. Send custom email notifications with your agreement contents and signed agreement
        2. Get your Adobe Acrobat Sign notifications in a Teams Channel
        3. Get your Adobe Acrobat Sign notifications in Slack
        4. Get your Adobe Acrobat Sign notifications in Webex
      6. Agreement generation
        1. Generate document from Power App form and Word template, send for signature
        2. Generate agreement from Word template in OneDrive, and get signature
        3. Generate agreement for selected Excel row, send for review and signature
  5. Custom Send workflows
    1. Custom Send Workflow Overview
    2. Creating a new Send Workflow
    3. Edit a Send Workflow
    4. Activate or Deactivate a Send Workflow
    5. Send an agreement with a Send Workflow
  6. Share users and agreements
    1. Share a user
    2. Share agreements

Integrate with other products

  1.  Acrobat Sign integrations overview 
  2. Acrobat Sign for Salesforce
  3. Acrobat Sign for Microsoft
    1. Acrobat Sign for Microsoft 365
    2. Acrobat Sign for Outlook
    3. Acrobat Sign for Word/PowerPoint
    4. Acrobat Sign for Teams
    5. Acrobat Sign for Microsoft PowerApps and Power Automate
    6. Acrobat Sign Connector for Microsoft Search
    7. Acrobat Sign for Microsoft Dynamics 
    8. Acrobat Sign for Microsoft SharePoint 
  4. Other Integrations
    1. Acrobat Sign for ServiceNow
    2. Acrobat Sign for HR ServiceNow
    3. Acrobat Sign for SAP SuccessFactors
    4. Acrobat Sign for Workday
    5. Acrobat Sign for NetSuite
    6. Acrobat Sign for VeevaVault
    7. Acrobat Sign for Coupa BSM Suite
  5. Partner managed integrations
  6. How to obtain an integration key

Acrobat Sign Developer

  1. REST APIs 
    1. Methods documentation
    2. SDK/Developer Guide
    3. API FAQ    
  2. Webhooks 
    1. Webhook overview
    2. Configure a new webhook
    3. View or edit a webhook
    4. Deactivate or reactivate a webhook
    5. Delete a webhook
    6. Two-way SSL certificates
    7. Webhooks in the API

Support and Troubleshooting

  1. Customer Support Resources 
  2. Enterprise Customer Success Resources 

The Adobe Acrobat 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:

  • Signing Reasons - Provides for the signer to apply a reason for their signature

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.

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
Recipient's challenge for phone authentication

Signing Reasons

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:

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

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)  
  • Acrobat Sign authentication
  • One-Time Password via Email (OTPvE)

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 Acrobat Sign account to authenticate with.
    • Only enable OTPvE if you intend to require a cloud-based digital signature.
  • 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 the following identity authentication methods for recipients: Acrobat Sign authentication.
    • Authenticating with the Acrobat Sign log-in is costly and has less friction than the SMS solution.
  • By default, use the following method: Acrobat Sign authentication.
  • Allow senders to change the default authentication method: Disable.
Navigate to Identity Authentication on teh Send Settings tab

How to enable or disable

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

Navigate to teh Enforced Identity Authentication controls on the Bio-Pharma tab

Things to keep in mind...

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If you still have questions you can contact support for assistance.

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