Redwood: Use Electronic Records and Electronic Signatures When Reporting Quality Inspection Results

Critical transactions governed by the U.S. Food and Drug Administration's (FDA) Good Manufacturing Practices (GMP) requirements include built-in validations that necessitate the use of electronic signatures (e-signatures) and electronic records (e-records).

With this update, you can capture an e-signature approvals and view the corresponding e-record when reporting inspection results via the Redwood user experience.

Approval Submission in the Redwood Format

Approval Submission in the Redwood Format

E-Signature Approval in the Redwood Format

E-Signature Approval in the Redwood Format

  • Ensures compliance with FDA 21 CFR Part 11 regulations through secure e-signature and e-record management
  • Reduces the risk of manual errors and improves data integrity in inspection reporting
  • Accelerates the approval process by enabling digital sign-off workflows

Here's the demo of these capabilities:

Steps to Enable

  1. Enable the opt-in for the "Capture Electronic Records and Electronic Signatures for Supply Chain Management Transactions" feature.
  2. Configure e-signature preferences by enabling Quality Inspection Disposition inline electronic signature approval for an organization under the task "Configure Electronic Signature Preferences". Refer to Configure E-Signature Preferences.
  3. After you enable electronic signatures for a transaction, you should also define configurable business process rules in Oracle Business Process Management using the Manage Task Configurations for Supply Chain Management task, and the Manage Approval Groups task in the Setup and Maintenance work area to determine the approvers for each transaction.

Tips And Considerations

  • The electronic signature approval is supported only through the user interface. Electronic signature approval cannot be provided using REST resources.

Key Resources

Access Requirements

Users who are assigned a configured job role that contains these privileges and codes can access this feature:

Quality Inspection Management Privileges :

  • Edit Inspection Results (QA_EDIT_INSPECTION_RESULTS)

Electronic Signature Approval Privileges  :

  • Electronic Signatures (EDR_ADD_ESIGNATURES_TRANSACTIONS_PRIV)
  • View Electronic Records and Signatures (EDR_VIEW_RECORDS_ESIGNATURES_PRIV)