You are on page 1of 33

An Oracle White Paper

April 2013
Oracle Pedigree and Serialization Manager:
Creating Your Own Pedigree



Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

Executive Overview ........................................................................... 2
Introduction ....................................................................................... 2
Downloading the template for modification ........................................ 6
Template Downloads using BI Publisher ....................................... 6
Template Downloads using Template Builder in Microsoft Word ... 8
Modifying the template .................................................................... 11
Making your data available .......................................................... 11
Adding information ....................................................................... 13
Removing information .................................................................. 22
Uploading your modified template ................................................... 24
Uploading the template using Template Builder ........................... 24
Uploading the template manually using BI Publisher ................... 25
Setting your new template as the report default (optional) ............... 28
Conclusion ...................................................................................... 30
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

2
Executive Overview
Counterfeit medicines are a worldwide problem and threat to public safety. Many healthcare
and life sciences organizations are facing increased supply chain and brand integrity risks due
to counterfeit and diverted drugs entering the drug distribution supply chain. As a result, many
countries are moving towards implementing regulations that will allow better tracking of drug
products throughout the supply chain, including serialization of products at the lowest saleable
unit. Some regulations are moving towards requiring a pedigree for tracking products. This
pedigree is a record that contains information about each distribution and transfer of ownership
of a prescription drug. It records product information as well as the sale of an item by a
pharmaceutical manufacturer, any acquisitions and sales by wholesalers or re-packagers, and
final sale to a pharmacy or other entity administering or dispensing the drug. Oracle Pedigree
and Serialization Manager (OPSM) is an application that Oracle has developed to help
companies comply with these regulations. This white paper will demonstrate how OPSM and
its integration with Oracle BI Publisher can help your company stay current with the ever-
evolving requirements for these pedigree documents.

Introduction
With the regulatory requirements for drug pedigrees constantly changing and evolving, Oracle
Pedigree and Serialization Manager was designed to provide a solution that allowed maximum
flexibility to grow and adapt to these changes. It is designed to work alongside existing
transactional systems to minimize impact on day to day operations. OPSM has the ability to
generate and manage serials in GS1 SGTIN standard format as well as allowing companies to
generate serial numbers using their own serial algorithm. Other features include:
Accessibility to data through role-based application user interface, portal and web services
The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. In developing
countries, where drug regulatory systems can be weak or non-existent, around 1030% of medicines might be counterfeit.
The Lancet, Volume 371, Issue 9624, Page 1551, 10 May 2008
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

3
Sharing of serialized product data across the supply chain
Support for the import of serial data for shipments and return receipts entered into your
transactional system
Support of inference through the use of packaging hierarchy, allowing transacted information
from the parent packaging level to cascade through all child levels contained in that
package.
Business analytics for counterfeit threat assessment
In addition to these features, OPSM provides the capability to generate electronic pedigrees in
xml format which can then be exported or used to product a printable document format. To
produce the printable document format, OPSM comes with a built-in integration to BI
Publisher. By integrating with BI Publisher, OPSM offers you the capability to personalize and
print pedigrees based on the business needs of your company.
For this white paper, we will show you how to modify the generic pedigree provided with
OPSM (Figure 1) into the personalized Pedigree that highlights certain features of the pedigree
(Figure 2)
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

4

Figure 1 - Original Pedigree
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

5

Figure 2 - Modified Pedigree


The steps to modify the pedigree template are as follows:
1. Download the template for modification
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

6
2. Add / Remove fields to update the template
3. Upload the modified template to the report
4. Mark the new template as the default report (optional)
Downloading the template for modification
Before modifying either of the provided pedigree templates, you need to download them from the BI
Publisher repository. This can be accomplished two different ways. The first is within the BI
Publisher application itself. The other is by using the Template Builder within Microsoft Word. The
following information will guide you through both of these methods.
Template Downloads using BI Publisher
From the BI Publisher home page, navigate to the OPSM Pedigree report by clicking the following
path: OPSM > Pedigree.


Figure 3 - Pedigree Report showing report menu

Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

7

From the Pedigree report menu, click the Edit link. This will open the Report Properties page.

Figure 4 After clicking the Edit link under the report, the Report Properties page displays

Choose Layouts from the Report tasks
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

8

Figure 5 - Create Layouts page is displayed when the Layouts link is clicked

Under the Manage Template Files section you will see both the Generic pedigree (GenericPedigree.rtf)
and Florida pedigree (PedigreeFloridaXML.rtf) templates. Select the link of the template you wish to
modify and, when prompted, save the file to a location where you can easily find it.
Template Downloads using Template Builder in Microsoft Word
Open Microsoft Word and logon to BI Publisher using the logon option under the Oracle BI Publisher
menu.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

9

Figure 6 - Log on to BI Publisher using the "Log On" option under the Oracle BI Publisher menu

In the Open Template dialog, select My Folders > OPSM

Figure 7 - Select the OPSM folder under My Folders

Under reports select the Pedigree report and the templates should appear in the Layout Template
region below it.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

10

Figure 8 - Select the Pedigree report to see all of the associated templates

Select the template you would like to modify and click the Open Layout Template button.
Please note: when you download a template using Template Builder, it does not
automatically have the name of the template that was downloaded, instead it is called
templateX.rtf where X is a number that is applied automatically for every template you
open.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

11

Figure 9 - Select the template you would like to modify from the list
Modifying the template
After you have downloaded your template, you can modify it using the Template Builder in Microsoft
Word. (Note: Make sure that you are logged into BI Publisher before you begin.)
Making your data available
After logging into BI Publisher using the menu option in Microsoft Word and opening up your
template, make sure that your data is available. To do so, from the Oracle Bi Publisher menu, select
Open
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

12

Figure 10 - - Select the template you are modifying from the list to access the associated data

When the Open Template dialog box opens, navigate to the OPSM folder under My Folders and select
the Report and Report Template that you are modifying. Click Open Report in order to load your
report data to the Template Builder. After you click the Open Report button, the dialog will close.
You will not get a confirmation that the data has loaded, but it will be available via the Insert menu on
the BI Publisher toolbar. After you have performed this step, choose the Data menu option from the
BI Publisher toolbar and select Load XML Data. A dialog box will open showing the .xml file that was
created when you clicked the Open Report button. Select this .xml file and click Open. You will
receive a message here that the data was successfully loaded.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

13

Figure 11 - Loading the data
Adding information
Once your data has been loaded, you can begin adding elements to your template. To do so, open the
Field dialog box by clicking Insert > Field on the BI Publisher toolbar:
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

14

Figure 12 - The Insert Field dialog box displays all available fields

Within the dialog you will see all of the fields available in the Pedigree XML stored in the database. To
add a field, simply place your cursor on the template where you would like the field inserted, select the
field in the dialog box that you would like to add and click Insert. The field will be added to the
template. Once the field has been inserted, you can use Microsoft Word formatting on that field to
change the font type, color, style, etc. Simply highlight the field and apply the format.
For our example, we will add the drug name and strength to the top of the form, and change the font
so that it will be easier to identify which drug the pedigree belongs to quickly and easily. We will move
the transaction information up on the pedigree so that it is more prominent. Finally, we will add a
company logo to the pedigree so that downstream partners can quickly identify the company that
originated the pedigree.
First, type the title Drug Name / Strength in the document.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

15

Figure 13 - Adding new title information

After the title, insert the Drugname by highlighting the Drugname field in the field dialog box and
clicking the insert button:
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

16

Figure 14 - Insert the drugName field

Add a / after the drugName field with spaces to clearly separate the data. Next highlight the
Strength field and insert it into the form.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

17

Figure 15 Insert the strength field

Finally, we will change the font by highlight both fields and choosing an easy-to-read font from the
available list in Microsoft Word.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

18

Figure 16 - Choose a new font format


Next we will Move the transaction information further up on the page. To do so, highlight the
information that you would like to move.

Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

19

Figure 17 - Highlight the Transaction region
Right click on the highlighted region and select Cut from the menu. Move your cursor to above the
Ownership section, right click and select Paste from the menu.

Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

20

Figure 18 - Transaction section moved above Ownership section

Finally, we will add our company logo to the form. We will insert the logo into the header section so it
will print at the top of every page. To expose the header section, choose View > Header from the
menu. Insert the cursor into the header section and select Insert > Picture > From File. When the
dialog box opens, navigate to your logo and click Insert.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

21

Figure 19 - Select the logo to insert

The logo will be inserted into the document.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

22

Figure 20 - After logo is inserted into template
Removing information
Removing fields from your template is as simple as highlighting the field and clicking the delete button
on your computer. There are no additional steps required. In our example, lets remove the street 2
from the seller address.
In the template, highlight the street2 field in the Ownership section under Seller.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

23

Figure 21 - Highlight street2 field
Right click on the field and select Delete from the menu or simply press the Delete key on your
keyboard. The field is removed.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

24

Figure 22 - street2 Field is Removed

Uploading your modified template
Now that we have modified your template, we must upload it to BI Publisher to use it. This can be
done one of two ways. The first is by using Template Builder in Microsoft Word. The other, is by
manually uploading the template using BI Publisher.
Uploading the template using Template Builder
To upload your template using Template Builder, simply select Update Layout Template from the
Oracle BI Publisher menu.

Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

25

Figure 23 - Upload the template using the Upload Template As... option

The modified template will replace the original template within BI Publisher. You can also choose the
Upload Template As option if you would like to upload the template to BI Publisher under a
different name.
Uploading the template manually using BI Publisher
To upload your template using BI Publisher, navigate to the Pedigree report as you did when
downloading the template by selecting the OPSM folder under My Folders and then clicking the Edit
link. Once the Report Properties page is open, click the Layouts link on the left side.

Choose the Layouts link from the navigation on the left side of your screen:
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

26

Figure 24 - Clicking the Layouts link on the left displays the Create Layouts page

Within the Manage Template Files section you will see an Upload Template field. Using the Browse
button, navigate to the template you would like to upload and select it. Then click the Upload button.
If you wish to replace an existing template with the modified template, please ensure that it has the
same name as the template you wish to replace.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

27

If you wish to create a new layout version with your modified template, click the New icon and give
your new layout a name (E.g. MyNewPedigree as shown in the screenshot above). Select the template
you have just uploaded from the Template list. Select your desired output formats (HTML, PDF, etc.).
Click the Save icon.
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

28
Setting your new template as the report default (optional)
Optionally you can set your new pedigree as the default. To do so, while still in the Create Layouts
page above from the Default Template drop down menu, choose the template that you modified or
the name of the new template that you created (if you chose the Upload Template As option).
Click the Save button to save your changes.

Figure 25 - Setting the new default pedigree template

To view your new pedigree document, simply choose View from the menu in the upper right corner of
BI Publisher:
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

29

Figure 26 - Choose View from the menu to see the new Pedigree report
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

30

Figure 27 - New Personalized Pedigree
Conclusion
Oracle Pedigree and Serialization Managers integration to BI Publisher provides customers with a
versatile method of creating and modifying personalized Pedigree documents to suit their needs.
Modification can be achieved in 4 simple steps as demonstrated in this white paper:
Oracle White Paper Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree

31
1. Download the template for modification
2. Add / Remove fields to update the template
3. Upload the modified template to the report
4. Mark the new template as the default report (optional)
Calling upon the powerful formatting capability of Microsoft Word and ease of data access via the
Template Builder, BI Publisher gives the non-technical user the ability to modify reports eliminating
the need for IT intervention. This allows faster turnaround of new reports in an environment that is
constantly changing and evolving.












\
Oracle Pedigree and SerializationManager:
Modifying Existing Pedigree Templates in BI
Publisher

April 2013
Author: Karla Biggs-Gregory


Oracle Corporation
World Headquarters
500 Oracle Parkway
Redwood Shores, CA 94065
U.S.A.

Worldwide Inquiries:
Phone: +1.650.506.7000
Fax: +1.650.506.7200
oracle.com
Copyright 2013, Oracle and/or its affiliates. All rights reserved. This document is provided for information purposes only and the
contents hereof are subject to change without notice. This document is not warranted to be error-free, nor subject to any other
warranties or conditions, whether expressed orally or implied in law, including implied warranties and conditions of merchantability or
fitness for a particular purpose. We specifically disclaim any liability with respect to this document and no contractual obl igations are
formed either directly or indirectly by this document. This document may not be reproduced or transmitted in any form or by any
means, electronic or mechanical, for any purpose, without our prior written permission.

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective
owners.

AMD, Opteron, the AMD logo, and the AMD Opteron logo are trademarks or registered trademarks of Advanced Micro Devices. Intel
and Intel Xeon are trademarks or registered trademarks of Intel Corporation. All SPARC trademarks are used under license and are
trademarks or registered trademarks of SPARC International, Inc. UNIX is a registered trademark licensed through X/Open
Company, Ltd. 0410

You might also like