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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.
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.
GE Intelligent Platforms' 21 CFR Part 11 Services
GE Intelligent Platforms offers 21 CFR Part 11 consulting services to assist you with your goal of achieving 21 CFR Part 11 compliance. By using these services, you can reduce the time, effort, and expense of developing, implementing, and maintaining a compliant solution to meet the regulation.

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.
      - GE Intelligent Platforms' 21 CFR Part 11 Services
        GE Intelligent Platforms offers 21 CFR Part 11 consulting services to assist you with your goal of achieving 21 CFR Part 11 compliance. By using these services, you can reduce the time, effort, and expense of developing, implementing, and maintaining a compliant solution to meet the regulation.
    - 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

GE Intelligent Platforms' 21 CFR Part 11 Services

GE Intelligent Platforms offers 21 CFR Part 11 consulting services to assist you with your goal of achieving 21 CFR Part 11 compliance. By using these services, you can reduce the time, effort, and expense of developing, implementing, and maintaining a compliant solution to meet the regulation.

These services include:

Training
Assessment
Detailed Detection
Maintenance

For more information, contact your GE Intelligent Platforms representative.