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Oracle Process Manufacturing Regulatory Management User's Guide
Release 12.1
Part Number E13693-04
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Oracle Process Manufacturing Regulatory Management User's Guide

Contents

Title and Copyright Information

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Preface

Regulatory Management Overview

Regulatory Management Processes
Setting Up Regulatory Management

Document Management

Requirements
Understanding Document Management
Setting Up Oracle Approvals Management
Using the Evidence Store
Uploading Regulatory Documents
MSDS for Shipping
Uploading Documents

Defining Regulatory Item Information

Defining Prerequisites
Finding Regulatory Item Information
Viewing Regulatory General Item Information for Existing Items
Viewing Exploded Components
Viewing Master Item Associations

Setting Up Regulatory Management

Defining Disclosure Code
Viewing Properties
Viewing Field Name Classes
Defining Field Names
Editing Field Name Class Assignments
Viewing Hazard Classification Codes
Defining Risk Phrase Details
Defining Safety Phrases Details
Setting Up Profile Options
Setting Up Territory Profiles
Defining Item Relationships
Editing Organization Items
Using the Formulator Workbench

Managing Hazard Communications

Managing Chemical Hazard Safety Documentation
      Understanding Chemical Hazard Regulations
      Producing Compliant Hazardous Material Documentation
      Generating Safety Labels
      Producing New Product Safety Documentation
      Creating and Distributing the Safety Data Sheet
      Managing Changes to Product Formulations
      Shipping and Transporting Hazardous Materials
      Storing, Approving, and Accessing Safety Documentation
      Distributing Updated Safety Documentation
      Storing and Accessing Current Safety Data Sheets
      Displaying Regulatory Items and Properties
Processing New and Updated Safety Documentation
Dispatching a Safety Document From an Oracle Partner
Dispatching a Safety Document Internally
Attaching and Printing Safety Documents with Shipments
Setting Up Transaction Types in the XML Gateway
Understanding OPM Hazard Communication Workflows
      Technical Overview
      Understanding Workflow Processes
      OPM Hazard Communication Workflows
Setting Up OPM Hazard Communication Workflows
      Document Rebuild Required Workflow
      Partner Application Data Change Workflow
      Regulatory Item Information Request Workflow
Understanding OPM Hazard Communication XML Messages
      OPM Hazard Communication XML Messages
Entering the Dispatch History
Finding a Dispatch History Record

Running Regulatory Management Reports

Disclosure Code Details Report
Field Name Class Codes Report
Field Name Codes Report
Properties Report
Risk Phrases Report
Safety Phrases Report
XML Publisher Report
Document Dispatch History Report
Print Regulatory Documents Report
Viewing Lookups
Viewing Session Parameters

Navigation Paths

Navigation Paths

Regulatory Management APIs

Regulatory Management APIs
Introducing the Regulatory Management APIs
Regulatory Management API Support Policy
Technical Requirements
Technical Overview
Basic Business Needs
Input Data Sources
Stored Procedure
Standard Parameters
Value-ID Conversion
Dispatch History API

Glossary

Index