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

This topic shows how to upload external documents such as Material Safety Data Sheets (MSDS) using Files Approval System. Using Oracle E-Records and setting up Oracle Approvals Management (AME) are also explained.

This chapter covers the following topics:

Requirements

Does OPM Regulatory Management have an approval process for new and updated documents?

OPM Regulatory Management enables both new and updated documents to be uploaded and routed through an approval process before being published or distributed. The approval process supports the entry and management of 21 CFR Part 11 compliant e-signatures. This signature must contain two distinct components. The Oracle E-Business Suite uses the user ID and password for the approval process.

Can regulatory documents be attached to items and shipments?

OPM Regulatory Management stores MSDS and regulatory documents associated to an OPM record in Oracle E-Records which provides full audit trail and CFR compliance tracking. The documents can be sourced internally, or they can be gathered externally from third party Regulatory providers. Attaching or modifying documents is controlled through iSignatures Files Approval.

Understanding Document Management

Optionally, Oracle Workflow enables regulatory documents to be submitted for approval before they are made available for general distribution. Approvers are defined in Oracle Approval Manager.

Oracle E-Records provides an interface that lets you search and display historical versions of a document. Search by document name, category, author, or status. You can also display user-defined values for each document based on the document category. And, you can search by user-defined values.

You can automatically attach approved regulatory documents to a shipment or manually to any other entity. Only the most recent version of each approved document can be attached to a shipment. View historical versions from the Oracle E-Record Evidence store.

Setting Up Oracle Approvals Management

Oracle Approvals Management is a self-service web application that lets you define business rules governing the process for approving transactions in other Oracle Applications. The purpose of AME is to define approval rules that determine the approval processes for Oracle Applications. Rules are constructed from conditions and approvals.

See: Oracle Approvals Management User's Guide

Create transaction attributes, conditions, approval groups, and approval rules within AME. The appropriate approvers are determined using the document category in iSignatures Files Approval.

Using the Evidence Store

E-records are stored in an evidence store. The evidence store provides a secure storage location and links to transaction windows. You can query the e-records repository using the evidence store. The Evidence Store window is divided into two regions. The top region lets you specify the query criteria and the bottom region shows the results of the query.

See Also

Oracle E-Records Implementation Guide

Uploading Regulatory Documents

Upload external documents using the iSignatures Files Approval. Each document is assigned a category that contains rules for the approval process. Each category has fifteen descriptive flexfield segments used to store information about the documents in that category. This information is stored in the database with the document, and can be used to search for the document.

Following are the four seeded Regulatory MSDS document categories used to determine the appropriate approvers:

See Also

Oracle Approvals Management User's Guide

Oracle E-Records Implementation Guide

MSDS for Shipping

The MSDS for Shipping lets you automatically or manually attach documents to shipping transactions.

Uploading Documents

Documents can be attached either automatically or manually.

Automatic

Using the Document Management Information in the OPM Regulatory Management responsibility or Files Approval in the iSignature Responsibility, you can upload a document into the FND tables. You must use a seeded or user-defined category for the shipping transactions to automatically print the document. The user defined category user description must contain the word Safety, MSDS, or Hazard.

Refer to the Oracle E-Records Implementation Guide for details on uploading a document.

Manual

Documents attached manually to a sales order or shipping transaction using the Attachment option for the user-defined categories can be enabled on any window. The user defined category user description must contain the word Safety, MSDS, or Hazard.

You can manually attached a document to both the sales order line and the shipping transaction.

Prerequisites

Adding the Regulatory Document Summary API to a Document Set

In order for an uploaded Regulatory document to print with a Shipment, the Regulatory Document Summary API (Concurrent Program) must be added to a Document Set.

In the Shipping Module, the Regulatory Document Summary API is added on the Document Set window for the Usage Ship Confirm. When Ship Confirm is performed, the Regulatory documents is printed.

  1. Navigate to the Order Management Super User, Process Operations (USA) responsibility.

  2. Navigate to Document Sets from Setup Documents. The Document Sets window displays.

  3. Query for the Document Sets with the usage: Ship Confirm. There can be many Document Sets, but you must choose the set that is used to print documents with a shipment. The query returns existing document sets. Now, add in the documents block.

  4. Enter Sequence in the serial order.

  5. Enter the Application Process Regulatory Management.

  6. Enter Report Name Regulatory Document Summary API.

  7. Enter Copies as 1. Number of copies required.

  8. Save the information.

To attach a document to a sales order line:

  1. Navigate to the Sales Orders window from the Order Management responsibility.

  2. Create and save a sales order.

  3. Navigate to the Line Items tab.

  4. Click the line you want to attach the document to and click the Attachments icon. The Attachments window displays.

  5. Enter a Sequence number and select the list of values for the Category. The list of values displays the seeded categories or any user-defined categories containing the words MSDS, Hazard, or Safety.

  6. Enter a description and select the DataType of File.

  7. Ensure that the Entity Name is OM Order Line.

  8. Save the attachments. All attached documents are automatically printed with the sales order line.

To attach a document to a shipping transaction:

  1. Navigate to the Shipping Transaction window from the Order Management responsibility.

  2. Select an order and click the Attachments icon. The Attachments window displays.

  3. Enter a Sequence number and select the list of values for the Category. The list of values displays the seeded categories or any user-defined categories containing the words MSDS, Hazard, or Safety.

  4. Enter a description and select the DataType of File.

  5. Ensure that the Entity Name is WSH Delivery Details.

  6. Save the attachments. All attached documents are automatically printed with the shipping transaction.