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Adobe Acrobat Sign 21 CFR part 11 Validation Package

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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. Add a User
    2. Add Users in Bulk
    3. Add Users from your Directory
    4. Add Users from MS Azure Active Directory
    5. Check for users with provisioning errors
    6. Change Name/Email Address
    7. Edit a user's group membership
    8. Edit a user's group membership through the group interface
    9. Promote a user to an admin role
    10. User Identity Types and SSO
    11. Switch User Identity
    12. Authenticate Users with MS Azure
    13. Authenticate Users with Google Federation
    14. Product Profiles
    15. Login Experience 
  3. Account/Group Settings
    1. Settings Overview
    2. Global Settings
      1. Account tier and ID
      2. Self Signing Workflows
      3. Send in Bulk
      4. Web Forms
      5. Custom Send Workflows
      6. Power Automate Workflows
      7. Library Documents
      8. Collect form data with agreements
      9. Limited Document Visibility
      10. Attach a PDF copy of the signed agreement 
      11. Include a link in the email
      12. Include an image in the email
      13. Files attached to email will be named as
      14. Attach audit reports to documents
      15. Merge multiple documents into one
      16. Upload a signed document
      17. Delegation for users in my account
      18. Allow external recipients to delegate
      19. Authority to sign
      20. Authority to send
      21. Power to add Electronic Seals
      22. Set a default time zone
      23. Set a default date format
      24. Users in Multiple Groups (UMG)
        1. Upgrade to use UMG
      25. Group Administrator Permissions
      26. Replace recipient
      27. 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
      28. In Product Messaging and Guidance
      29. Accessible PDFs
      30. New authoring experience
      31. Healthcare customer
    3. Account Setup
      1. Add logo
      2. Customize company Hostname/URL    
      3. Add company name
    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. Decline to sign
      8. Allow Stamps workflows
      9. Require signers to provide their Title or Company
      10. Allow signers to print and place a written signature
      11. Show messages when e-signing
      12. Require signers to use a mobile device to create their signature
      13. Request IP address from signers
      14. 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. Restricted Cloud Signatures Providers
    6. Electronic Seals
    7. Digital Identity
    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. Recipient groups
      6. Required fields
      7. Attaching documents
      8. Modify Agreements
      9. Agreement name
      10. Languages
      11. Private messages
      12. Allowed signature types
      13. Reminders
      14. Signed document password protection
      15. 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
      16. Content Protection
      17. Enable Notarize transactions
      18. Document Expiration
      19. Preview, position signatures, and add fields
      20. Signing order
      21. Liquid mode
      22. Custom workflow controls
      23. Upload options for the e-sign page
      24. 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. Custom 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. GDPR
      1. GDPR Overview
      2. Redact a user
      3. Redact a user's agreements    
    3. 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
    4. Healthcare customers
    5. IVES support
    6. eOriginal vaulting for chattel paper
    7. 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 

Send, Sign, and Manage Agreements

  1. 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. Send in Bulk - manual recipients
      2. Send in Bulk - CSV upload
      3. Cancel a Send in Bulk transaction
      4. Add reminders to Send in Bulk
      5. Reporting for Send in Bulk
  2. 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 
  1. Authoring FAQ
  2. Sign Agreements
    1. Sign agreements sent to you
    2. Fill & Sign
    3. Self-signing
  3. 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. 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
  4. Audit Report
  5. 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. Edit a data export
      3. Refresh the data export content
      4. 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. Track Power Automate usage
    4. Create a new flow (Examples)
    5. Triggers used for flows
    6. Importing flows from outside Acrobat Sign
    7. Manage flows
    8. Edit flows
    9. Share flows
    10. Disable or Enable flows
    11. Delete flows
    12. 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

Adobe offers a package of validation document templates to assist Adobe Acrobat Sign customers in documenting compliance with FDA’s 21 CFR Part 11 regulatory requirements pertaining to electronic signatures. These templates are designed to be adapted and executed by customers according to their internal compliance validation strategy procedures and governance as well as assist in establishing documented evidence that their system is fit for its intended use.

Within the validation package, the following typical use cases are considered:

  1. Send to internal signers - signing a document by multiple internal signers (no external signers)
  2. Self-signing - signing a document by a single internal signer who is also the sender (no external signers)
  3. Send to external signers - signing a document by one or more external signers (no internal signers)
  4. Send to both internal and external signers - the signing of a document by internal and external signers

Contents of the validation package include:

  1. Validation plan which describes the approach, roles and responsibilities, and deliverables that comprise the Acrobat Sign validation effort.
  2. Regulatory impact assessment which is used to assess the regulatory impact of using Acrobat Sign for the application of electronic signatures to electronic records. This document also identifies the technical and procedural controls required for system conformance with 21 CFR Part 11 regulations.
  3. System requirements specification which includes:
    1. Requirement specifications that outline business (end-user), functional, security, and regulatory requirements
    2. Functional specifications, that describe system functions and features needed to meet the specified requirements
    3. Configuration specifications that describe how the system must be configured to meet the specified requirements
  4. Validation test protocol (including test scripts) which provides a framework that governs the verification and testing to produce documented and objective evidence that Acrobat Sign has been configured correctly and operates as intended, in accordance with specified requirements. The protocol oversees the execution of test scripts, which include detailed instructions to verify the configuration of the Acrobat Sign account and to perform functional testing.
  5. Work instruction which describes Acrobat Sign account administration activities and establishes a process for the application of electronic signatures.
  6. Requirements traceability matrix which captures the relationship between specified requirements and the testing activities and/or procedures that demonstrate and ensure each requirement is satisfied.
  7. Validation summary report which provides a summary of the overall validation exercise, capturing the list of deliverables produced and reporting on the test results, and concludes with a statement of fitness for the intended use.

Validation package activities are intended to be executed using a configured Acrobat Sign enterprise plan service with SAML settings that are enabled for internal users to authenticate using their network credentials. The Acrobat Sign 21 CFR Part 11 validation package is available in English only and was prepared through a collaboration between Adobe and Montrium Inc.

Download the Adobe Acrobat Sign 21 CFR Part 11 validation pack from Montrium

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