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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.
Electronic Signature Tracking
Each time an operator signs an action, a detailed electronic record is written to the electronic signature audit trail.

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- 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.
    - Audit Trail Reports
      Workflow provides the ability to generate reports based on your audit trail and electronic signature data.
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Best Practices

Electronic Signature Tracking

Each time an operator signs an action, a detailed electronic record is written to the electronic signature audit trail.

Records written to the electronic signature audit trail:

Ensure a tamper-resistant, time-stamped, permanent record of operator actions.
Include the user names and full names of all performers and verifiers involved in signing and verifying actions.
Include all comments entered by the performers and verifiers involved in signing and verifying actions.
Include the unaltered description of the action signed for by the operator and as displayed in the E-Signature Area at the time of signing.
Are recorded in your SQL Server database.

Electronic signature tracking starts when an operator clicks the Sign Form button on a form in a running workflow. An initial record is then created in the ElectronicSignature table in the SQL Server database with a state of Awaiting Performer. When the performer signature is completed, the record state is updated to Awaiting Verifier or Completed, depending on whether a verifier signature is required. The electronic signature related to a completed task form can be viewed from the Completed Task Information. If the signing is cancelled at any time, the state is updated to Cancelled and if the signing fails it is updated to Failed. For information on electronic signature failures, see Failed Electronic Signature Examples.

Audit records for electronic signatures are created at the conclusion of the electronic signature whether it completed successfully, was cancelled, or failed.