Welcome to Release 12.1 of the Oracle Manufacturing Implementing Oracle E-Records in Discrete Manufacturing Guide.
This guide assumes you have read the Oracle E-Records Implementation Guide and are familiar with Oracle Discrete Manufacturing Applications.
See Related Information Sources for more Oracle E-Business Suite product information.
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This guide supplements the Oracle E-Records Implementation Guide, providing Oracle E-Records implementation information that is specific to the Oracle Discrete Manufacturing Applications.
This chapter discusses using Oracle E-Records with discrete manufacturing business processes to support compliance of Food and Drug Administration (FDA) regulations, specifically the FDA Code of Federal Regulations (CFR) Title 21 Part 11, otherwise known as 21 CFR Part 11.
This chapter provides an example of how to set up a transaction to capture e-records and e-signatures. It also discusses exceptions to the standard setup steps and setup process.
This chapter discusses strategies for you to consider using during Oracle E-Records implementation.
This appendix lists each window referred to in the Oracle Manufacturing: Implementing Oracle E-Records in Discrete Manufacturing Guide as well as the associated navigator path for each window by responsibility. It also lists the navigation path(s) for every Oracle E-Records enabled discrete manufacturing event.
This appendix shows collated and printed e-records created for the Device History Record Example.
The tables in this appendix detail the seed data entered to support each discrete manufacturing application integrated with Oracle E-Records.
The Oracle Integration Repository is a compilation of information about the service endpoints exposed by the Oracle E-Business Suite of applications. It provides a complete catalog of Oracle E-Business Suite's business service interfaces. The tool lets users easily discover and deploy the appropriate business service interface for integration with any system, application, or business partner.
The Oracle Integration Repository is shipped as part of the E-Business Suite. As your instance is patched, the repository is automatically updated with content appropriate for the precise revisions of interfaces in your environment.
This guide explains the purpose of Oracle E-Records as well as how to implement it. Use Oracle E-Records when you have organizations that want to maintain electronic documents or need the ability to electronically sign those documents, ensuring that the appropriate personnel have reviewed and approved them.
This guide explains how to define business rules governing the process for approving transactions in Oracle Applications where Oracle Approvals Management has been integrated.
This guide enables your engineers to utilize the features of Oracle Engineering to quickly introduce and manage new designs into production. Specifically, this guide details how to quickly and accurately define the resources, materials and processes necessary to implement changes in product design.
This guide describes how to define items and item information, perform receiving and inventory transactions, maintain cost control, plan items, perform cycle counting and physical inventories, and set up Oracle Inventory.
This guide describes how to create various bills of materials to maximize efficiency, improve quality and lower cost for the most sophisticated manufacturing environments. By detailing integrated product structures and processes, flexible product and process definition, and configuration management, this guide enables you to manage product details within and across multiple manufacturing sites.
This guide describes how Oracle Work in Process provides a complete production management system. Specifically, this guide describes how discrete, repetitive, assemble-to-order, project, flow, and mixed manufacturing environments are supported.
This guide describes how Oracle Quality can be used to meet your quality data collection and analysis needs. This guide also explains how Oracle Quality interfaces with other Oracle Manufacturing applications to provide a closed loop quality control system.
This guide explains how to implement Oracle Quality's nonconformance, disposition, and corrective action solution based on seeded templates.
This guide describes how to set up Oracle Shipping Execution to process and plan your trips, stops and deliveries, ship confirmation, query shipments, determine freight cost and charges to meet your business needs.
This guide describes how to create and approve purchasing documents, including requisitions, different types of purchase orders, quotations, RFQs, and receipts. This guide also describes how to manage your supply base through agreements, sourcing rules and approved supplier lists. In addition, this guide explains how you can automatically create purchasing documents based on business rules through integration with Oracle Workflow technology, which automates many of the key procurement processes.
This guide provides flexfields planning, setup, and reference information for the Oracle E-Business Suite implementation team, as well as for users responsible for the ongoing maintenance of Oracle E-Business Suite product data. This guide also provides information on creating custom reports on flexfields data.
Oracle STRONGLY RECOMMENDS that you never use SQL*Plus, Oracle Data Browser, database triggers, or any other tool to modify Oracle E-Business Suite data unless otherwise instructed.
Oracle provides powerful tools you can use to create, store, change, retrieve, and maintain information in an Oracle database. But if you use Oracle tools such as SQL*Plus to modify Oracle E-Business Suite data, you risk destroying the integrity of your data and you lose the ability to audit changes to your data.
Because Oracle E-Business Suite tables are interrelated, any change you make using an Oracle E-Business Suite form can update many tables at once. But when you modify Oracle E-Business Suite data using anything other than Oracle E-Business Suite, you may change a row in one table without making corresponding changes in related tables. If your tables get out of synchronization with each other, you risk retrieving erroneous information and you risk unpredictable results throughout Oracle E-Business Suite.
When you use Oracle E-Business Suite to modify your data, Oracle E-Business Suite automatically checks that your changes are valid. Oracle E-Business Suite also keeps track of who changes information. If you enter information into database tables using database tools, you may store invalid information. You also lose the ability to track who has changed your information because SQL*Plus and other database tools do not keep a record of changes.