My Oracle Support Banner

E1: CFR11: Troubleshooting the EnterpriseOne Auditing Tool 21CFR Part 11 Including Auditing Configuration Related Questions (Doc ID 2197018.1)

Last updated on JANUARY 14, 2020

Overview

Oracle's JD Edwards EnterpriseOne auditing and electronic signature tools provide a solution to the Food and Drug Administration's (FDA) acceptance of electronic signatures and audit records for FDA-required records such as product submissions, batch records, and complaints. These tools enable your organization to comply with the FDA 21 CFR Part 11 regulation for submitting electronic records.

Basically, this auditing tool provides the capability to select specific columns in a table for auditing. You can configure JD Edwards EnterpriseOne to generate an audit table when table records are inserted, updated, or deleted. The audit records contain data such as:

  • Before and after values
  • Time and date of the transaction
  • The user who made the modification

In addition, you can configure JD Edwards EnterpriseOne interactive and batch applications to require an electronic signature approval when a user tries to change the data on an application or submit a report. A record of the approval is recorded in the Signature table (F9500005). The table records this information:

  • Approver of the change
  • Reason for the approval
  • Approver's user ID
  • User’s role
  • Date and time of the approval

You can view the information in the audit and electronic signature tables using the View Audit/Signature Information application (P9500005) or by generating reports (R9500004, R9500005, R9600006). The reports display all the audit and signature information in an easy-to-read Adobe Acrobat PDF file that can be printed to hard copy or saved in digital format.

Purpose of Auditing

Any company is accountable for the data it stores. Any modification that is done to the data impacting the company financially or legally should be traceable to its source. The data may include sales/purchase orders ledger accounts, employee records etc. To meet this requirement, you can use EnterpriseOne Auditing Tool 21CFR Part 11.

Purpose of this Document

This document contains information related to issues while working in the 21CFR11 Auditing tool along with Auditing Configuration related questions. It includes issues encountered while enabling auditing, issues while disabling auditing and issues with audited data. This document also covers the methodology and steps to be used for troubleshooting 21CFR11 Auditing issues. 

 

To view full details, sign in with your My Oracle Support account.

Don't have a My Oracle Support account? Click to get started!


My Oracle Support provides customers with access to over a million knowledge articles and a vibrant support community of peers and Oracle experts.