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Data Administration
Electronic Signatures and Audit Trails
Purpose of Electronic Signatures
Electronic signatures are intended for application developers, process control engineers, and workflow users who want or need to incorporate electronic signatures and audit trails into their operations.
Configure Audit Trails and Electronic Signatures
The Audit/E-Signature editor is used to configure audit trails and electronic signature failure limits.
Failure Limits on Electronic Signatures
The Electronic Signature Configuration tab is used to configure the number of failed signing attempts before the electronic signature fails.

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- Data Administration Introduction
- Electronic Signatures and Audit Trails
  - Electronic Signatures and Audit Trails
    Workflow provides the ability to electronically sign forms in the run-time environment and to create an audit trail of those signatures, as well as audit other configuration changes made to the system.
  - Purpose of Electronic Signatures
    Electronic signatures are intended for application developers, process control engineers, and workflow users who want or need to incorporate electronic signatures and audit trails into their operations.
    - How to Use Electronic Signatures
      Electronic signatures are the computer-generated, legally-binding equivalents of handwritten signatures. They uniquely identify the persons responsible for an action.
    - Signatures During Workflow Run Time
      When a running workflow requires an electronic signature for a particular section, the appropriate operator must sign and/or verify the task/task step action or form; otherwise, the workflow will not proceed further.
    - Electronic Signature Tracking
      Each time an operator signs an action, a detailed electronic record is written to the electronic signature audit trail.
    - 21 CFR Part 11 Overview
      21 CFR Part 11 is a United States Government Food and Drug Administration (FDA)-mandated regulation that requires all electronic records and signatures, paperless records, and reporting procedures related to the manufacture of a product be captured and stored securely for businesses under its control, such as the Bio-Pharmaceutical and Food and Beverage industries.
    - Audit Trails
      Workflow provides audit trail capability that allows you to keep a traceable record of actions that are performed within your system. Actions that regulators are concerned with are typically those actions that commonly occur in a production environment.
    - Configure Audit Trails and Electronic Signatures
      The Audit/E-Signature editor is used to configure audit trails and electronic signature failure limits.
      - Configure electronic signatures for use during workflow run time
        You can configure electronic signatures to be available when a workflow is running to verify a task/task step action or a form.
      - Topics to be Audited
        The Audit Configuration tab is used to select the topics that will be audited when auditing is enabled in your system.
      - Failure Limits on Electronic Signatures
        The Electronic Signature Configuration tab is used to configure the number of failed signing attempts before the electronic signature fails.
        Configure failure limits for electronic signatures
        This procedure describes how to configure failure limits for electronic signatures.
        Failed Electronic Signature Examples
        Electronic signatures are configured with failure limits for added security. Failure limits prevent an unauthorized user from signing a form, or prevent an authorized user to enter incorrect credentials beyond the configured limit.
    - Audit Trail Reports
      Workflow provides the ability to generate reports based on your audit trail and electronic signature data.
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Failure Limits on Electronic Signatures

The Electronic Signature Configuration tab is used to configure the number of failed signing attempts before the electronic signature fails.

The configuration for failed signing attempts applies to the:

Specific role that is configured for a form activity.
Number of times a single user can attempt to sign an electronic signature instance before being locked out from successfully signing for one of the roles for that electronic signature instance.

The role for an electronic signature describes the role a user plays in the action being signed. There are two possible roles that a user can perform.

Performer: User who just performed the action.
Verifier: User who verifies the action performed and signed by the Performer.

Note: You can assign a single group to both the Performer and Verifier roles or different groups to each role. Only members of those groups are permitted to electronically sign a form, but the same user cannot sign for both roles.

For added security, you can configure the number of times an electronic signature can be attempted on a single role before failing. For information and examples on signature failure, see Failed Electronic Signature Examples.

The following table describes the available attributes.

Attribute	Value	Description
Failure Limit on Role	User-defined	Specifies the number of times an electronic signature for the assigned role (that is, Performer or Verifier) can fail before the electronic signature fails.
Failure Limit on Person	User-defined	Specifies the number of times a given user can attempt to sign a single electronic signature before the user is banned from signing in either the performer or verifier role for that electronic signature.