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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.
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.

Workflow Products Documentation

Data Administration
- 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.
    - Audit Trail Reports
      Workflow provides the ability to generate reports based on your audit trail and electronic signature data.
- Data Sources
- Archives
- Custom Property Types
- Transferring Workflow
- Reporting

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.

The audit trail is a key component in a 21 CFR Part 11 compliant system, but it can also be useful in many different applications. The electronic signature audit trail contains a computer-generated, time-stamped record of each electronic signature. Each record clearly identifies all pertinent information about the person who entered the signature, such as the person's name, the time the signature was entered, and, optionally, comments provided by the signer.

Enabling a workflow may require auditing because that is when the workflow changes are entering the live process. Actions that are rarely performed can be tracked by using a manual paper system.

When an action that is configured to be audited takes place, an audit record is written to the SQL Server database. The audit entry in the database includes the following information:

A time stamp indicating when the record was created.
An optional time stamp indicating when the action took place.
The location where the action took place (that is, the assigned equipment resource).
User context, which is any information related to the audit record and can include a bind to a workflow variable and/or an expression.
The associated topic.

Auditing can be enabled or disabled on a per topic basis; however, audit configuration changes and electronic signatures are always audited, regardless of whether the global auditing is enabled or disabled.