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Product Lifecycle Management Agile Recipe Management for Pharmaceuticals - Process Management Guide Release 9.3.3 E39302-01 |
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# 1 Introduction to Process Management

The Process Management module within the Agile PLM Recipe & Material Workspace (RMW) solution allows you to manage the processes involved in the development process of a chemical product.

## 1.1 About this Guide

This guide provides information on all the features and functionality of the RMW Material Management module. It also covers instructions on how to use the various menus and commands available on the RMW User Interface to create and manage material objects. The features that are visible to you on the interface are determined by the access privileges assigned to you by an administrator.

## 1.2 Recipe & Material Workspace Documentation

The complete list of RMW manuals is provided here for the benefit of users and administrators of the RMW solution.

- Getting Started with Recipe & Material Workspace - describes common concepts, basic navigation, searches and workflows. Also covers how to work with reports, standards, and environmental conditions.

- Recipe & Material Workspace Administrator Guide - describes all administration and configuration information including Agile PLM integration requirements.

- Recipe & Material Workspace Process Management - describes the features of the Process module, covering the creation and execution of projects and campaigns, control recipes, and work requests.

- Recipe & Material Workspace Recipe Management Guide - describes the features of the Recipe module, covering the authoring and management of recipes and recipe templates.

- Recipe & Material Workspace Material Management Guide - describes the features of the Materials module, covering how to work with material requests, inventory, and allocation. Also covers how to manage analytical activities.

- Recipe & Material Workspace Equipment Management Guide - describes the features of the Equipment module, covering equipment qualification, loan, lease, and reservation.

- Recipe & Material Workspace Import/Export Guide - describes how to export and import RMW business and administrator objects from a source system to a target system.

RMW is accessed only through the Agile PLM user interface. Refer to Getting Started with Agile PLM along with the Agile PLM Administrator guide for a thorough understanding of PLM processes. The complete set of Agile PLM documentation, including RMW documentation, is available on the Oracle Technology Network (OTN) Web site `http://www.oracle.com/technetwork/documentation/agile-085940.html`.

## 1.3 Process in RMW - An Overview

The following business processes are enabled through the Process Management module:

- Creating new Projects to track material being made in pilot plants or development areas.

- Associating recipes to Campaign or process steps within a Project and resolving resource placeholders to resources that are available at specified facility or site.

- Managing Bill of Processes (BOP), Bill of Material (BOM) and Bill of Equipment (BOE), and Bill of Standards (BOS) which are auto-created from a copy of recipe, to be carried over to the Control Recipe and the Work Request.

- Capturing all work completed in the work request, including materials made, materials consumed, control parameter settings and in-process measurements of materials.

- Releasing all material coming into Inventory from the Work Request using a formal Lot Release process.

- Completing Work Requests using a structured approach with re-usable Projects and Campaigns.

### 1.3.1 Process Structure

Description of the illustration ch1_01.gif

- Project - Plan what products are to be developed and set time lines.

- Campaigns - Identify target material, site for campaign execution, specify environmental impact and then eventually initiate the work request via the control recipe.

- Process Step - Specify Recipe with BOP, BOE, BOM, BOS specify environmental impact of process step, resolve resource variables, reserve and allocate material and equipment, and auto-create Control Recipes and/or Work Requests.

- Control Recipe - Resolve resources; create/manage inventory requests for BOM, reservation requests for BOE or Suite.

- Work Request - Resolve resources; and close out - Amount made as product or by-products is placed into inventory, results captured against materials made, equipment used (start and end time) and actual quantities of materials used.