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Oracle Manufacturing Implementing Oracle E-Records in Discrete Manufacturing Guide
Release 12.1
Part Number E13682-04
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Oracle Manufacturing Implementing Oracle E-Records in Discrete Manufacturing Guide

Contents

Title and Copyright Information

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Preface

Introduction

Using Oracle E-Records to Support Compliance of 21 CFR Part 11
Discrete Manufacturing Business Flows Using Oracle E-Records
      Design Transfer
      Design Change
      Demand to Build
      Nonconformance Management
      Corrective Actions Processing
      Procure to Pay
      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

Index