Oracle Manufacturing Implementing Oracle E-Records in Discrete Manufacturing Guide

Contents

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Introduction

Using Oracle E-Records to Support Compliance of 21 CFR Part 11

Discrete Manufacturing Business Flows Using Oracle E-Records

Design Transfer

Demand to Build

Nonconformance Management

Corrective Actions Processing

Oracle E-Records Enabled Transactions Summary

Oracle E-Records Setup and Process Exceptions in Discrete Manufacturing

Setting Up E-Records: A Discrete Manufacturing Example

Setup and Process Exceptions

Implementation Considerations

Using Additional Attributes

Modifying a Stylesheet to Include Descriptive Flexfields

Enforcing Nonconformance, Disposition, and Corrective Action Request Approvals

Capturing Non-Seeded Collection Elements in Nonconformance, Disposition, and Corrective Action E-Records for History Collection Plans

Creating a Device History Record

Windows and Navigation Paths

System Adminstrator Windows and Navigation Paths

Workflow Administrator Pages and Navigation Paths

Approvals Management Application Administrator Windows and Navigation Paths

ERES Administrator Windows and Navigation Paths

iSignatures User Pages and Navigation Paths

Manufacturing and Distribution Manager Windows and Navigation Paths

Application Developer Windows and Navigation Paths

Navigation Paths For All Oracle E-Records Enabled Discrete Manufacturing Business Events

Device History Record Example

Example of Collated and Printed E-Records

Oracle E-Records Event Data for Discrete Manufacturing

Event Data for Oracle Engineering

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data: Generic Query Attributes

Event Data for Oracle Inventory

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data: Generic Query Attributes

Event Data for Oracle Bills of Material

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data: Generic Query Attributes

Event Data for Oracle Work in Process

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data: Generic Query Attributes

Event Data for Oracle Quality

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data

Event Data for Oracle Purchasing

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data

Event Data for Oracle Shipping

Oracle Workflow Seeded Data

Events

Event Key

Event Subscription

Oracle Approvals Management Seeded Data

Oracle E-Records Seeded Data

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