The Oracle E-Records application supports Federal Food and Drug Administration's (FDA) code regulation 21 CFR Part 11. This regulation supports the creation of electronic records to monitor activities by regulated industries such as food, pharmaceuticals, and medical devices. These industries are subject to audit, retention of records, and capture of legally binding signatures.

Oracle Manufacturing support of these features enables compliance for companies falling under FDA regulation and similar global regulations. Manufactured product data is electronically captured and has a complete audit trail.

The e-records and e-signatures (ERES) framework uses Oracle Workflow business events and Oracle XML Gateway. This framework enables you to define event metadata to specify the reporting format for the event.

Setup

For setup information, see the Oracle E - Records Implementation Guide and the Oracle E - Records Developer's Guide. Setup for Work in Process involves the following:

• Set the Transaction Processing profile options to online mode. See: Profile Options

• Install Oracle Workflow in order to initiate the e-signatures (EDRPSIGF) workflow for sending notifications. The Workflow Business Event system is used to define an e-signature event and associate synchronous e-signature subscription to the event.

Work in Process E-Signature Transactions

The Work in Process transactions creating electronic signatures include material transactions, assembly moves, and assembly completions.

Material Transactions: The process is enabled when issuing a component from inventory, or returning a component to inventory. This includes the following transaction types:

• WIP issue

• WIP return

• WIP negative component issue

• WIP negative component return

Move Transactions: The process is enabled when you move assemblies within a routing, complete assemblies from a routing operation, or return completed assemblies from inventory to an operation routing. Quality results are included in the e - record. The following transaction types are included:

• Move

• Complete

• Return

Completion Transactions: The process is enabled when you complete an assembly and return it to inventory, or return a completed assembly from inventory to a job. Quality results are included in the e - record. This includes the following transaction types:

• WIP assembly completion

• WIP assembly return

Other Sources

• Evidence Store, Oracle E-Records Implementation Guide

• Implementing E-Records, Oracle E-Records Implementation Guide