Oracle Pedigree and Serialization Manager Process Guide Release 1.2 Part Number E36379-01

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Understanding Oracle Pedigree and Serialization Manager

This chapter covers the following topics:

• Oracle Pedigree and Serialization Manager Overview
• Product Code Types Supported

Oracle Pedigree and Serialization Manager Overview

Oracle Pedigree and Serialization Manager (OPSM) is an application that enables companies to manage serialization of products and share serialized product data across the supply chain. OPSM can integrate with your existing manufacturing, shipping, and receiving transactional systems, Oracle E-Business Suite (EBS), or it can operate as a standalone application. OPSM can support multiple transactional or EBS systems integrated to a single instance of OPSM. The multiple transactional or EBS systems may be multiple instances managed within your company or systems managed by your manufacturing and logistics partners.

This diagram illustrates a high-level overview of OPSM:

OPSM High-Level Overview

The OPSM application is broken out by functional area. These functional areas are:

• System Setup

• EPCIS Setup

• Serials

• Packaging

• Transactions

• Audit Trail

• Dashboard

In the System Setup area you define all the setup information used by OPSM in its processing. This includes system parameters, lookups, locations, location groups, products, and other set up information used for maintaining serial numbers (serial type groups and serial ranges, serial destinations, and serial destination rules).

In the EPCIS Setup area you define all of the setup information used by the EPCIS web services during their processing. This includes EPCIS preferences, policies, and users. The EPCIS web services enable you to populate the EPCIS repository with transaction events and to query on those events.

For more information, see Understanding the EPCIS repository.

In the Serials area you can generate serial numbers within OPSM or perform Work Order Serialization to generate serials based on the work order manufacturing yield. After serials are created, you can use OPSM to maintain those serial numbers. You can maintain individual serial numbers and their association with lots. Finally, in the Serials area you can maintain lot information such as, the lot expiration date and other lot dates.

In the Packaging area you can maintain packages and multilevel packaging hierarchies for inference purposes. This area is used to create new packages and manage packaging configurations such as, the association of serialized units packed into cartons, which may then be stacked on pallets and placed into a container. Inference can be used to facilitate the reporting of unused or voided codes for damaged, quarantined, or otherwise unused product units.

As material transactions are executed in external systems or within EBS against tracked serials, OPSM records the transaction and updates the state of the serial numbers. In the Transactions area, OPSM provides pages where you can view shipment, return, serial generation, serial transmission, import serials, commission serials, decommission serials, edit serials, and reserve serials transaction details. You can also edit serials associated to Shipment and Return transactions that are in an exception status. Finally, in Transactions, you can create, digitally sign, and print pedigrees for shipment transactions. Transaction exceptions can also be viewed and issues can be resolved and the transactions can be processed again.

In the Audit Trail area, OPSM gives you the ability to set up an audit trail for all of the data in the OPSM application and to view the results from that audit trail. Recording and auditing of this serial data can assist you in being 21 CFR Part 11 compliant.

For more information, see Understanding Auditing.

OPSM also provides a dashboard that delivers tactical business analytics related to product serial management. Using the dashboard you can view a variety of serialization and transaction metrics that can be used for monitoring the serials and transactions.

OPSM can operate in an integrated mode with external transactional systems, and/or EBS, or it can operate as a standalone application. Through the use of web services and file transfer exchanges external third party systems can integrate with OPSM enabling them to streamline their business processes. OPSM hosts a set of inbound and outbound services. The web services provided include:

OPSM Web Services

• Create Serial Generation Request

• Edit Status and Usage by Label

• Edit Status and Usage by List

• Edit Status and Usage by Primary Document

• Merge Lot

• Merge Product

• Pack Package

• Unpack Package

• Create Transaction (Shipments, Returns, and Imports)

EPCIS Repository Web Services

• CaptureService

• QueryService

OPSM provides open interface tables for batch upload of information for the set up of the products and item cross reference, synchronization of lots, and work orders for generation of serials. The interface tables provided include:

• Product Interface table

• Lot Interface table

• Work Order Interface table

OPSM can also integrate with EBS using the Application Integration Architecture (AIA) Integrations (Web Services, Oracle Data Integrator (ODI), and direct page transfers). The integrations between OPSM and EBS address the synchronization of product and lot information, creation of serials, and recording and/or tracking of serialized item events. The integrations record and/or track the following events:

• Synchronizing item and product information.

• Synchronizing lot information.

• Reserving serials for discrete manufacturing jobs and process manufacturing batches.

• Commissioning serials to the designated product and lot.

• Decommissioning serials when jobs or batches are cancelled or terminated.

• Shipping serialized items.

• Receiving returned serialized items.

For more information on the integration between OPSM and EBS, see the Oracle Serialization and Tracking Integration Pack for Oracle Pedigree and Serialization Manager and Oracle E-Business Suite 3.1 - Implementation Guide.

Key Features

OPSM provides several features. A few of the key features are:

• Serialization and Lot Management

  • Generate serials

  • Import serials

  • Maintain serials

  • Track current serial state

  • Commission serials

  • Decommission serials

  • Flag serials as counterfeit

  • Export serials

  • Maintain serial ranges

  • Maintain serial destinations

  • Maintain lots

  • Lot synchronization

  • Work order serialization

• Packaging Hierarchy and Packages Management

  • Maintain package hierarchy (structure)

  • Associate serialized components to serialized assembly

  • Serial disposition through packaging hierarchy

  • Maintain packages

  • Define and view alternate packaging IDs

  • Pack packages

  • Unpack packages

  • Package level serial disposition

• Transaction Management

  • View shipment transactions

  • View return transactions

  • View import serials transactions

  • View serial generation transactions

  • View serial transmission transactions

  • View commission serials transactions

  • View decommission serials transactions

  • View reserve serials transactions

  • View edit serials transactions

  • View transaction exceptions

  • Process transactions

  • Edit serials associated with Shipment and Return transactions at exception status

  • Transmit and retransmit serials on transactions

  • Create, digitally sign, and print Pedigree for shipment transactions.

• Audit Management

  • Set up audit trail

  • View audit trail history

• Oracle Pedigree and Serialization Manager Operations Dashboard

  • Out of the box serial and transaction metrics

    • Serials by Location (imported, generated, shipped, returned, commissioned, decommissioned, reserved, edited)

    • Location Information

    • Transaction Exceptions Metric (commissioned serials, decommissioned serials, reserved serials, edited serials, shipments, returns, imports, serial generations, and serial transmissions)

    • Counterfeit and Suspect Counterfeit Serials by Product and Location

    • Serial Range Management (remaining serials in range)

Product Code Types Supported

To process the serial number, certain product information must be available in Oracle Pedigree and Serialization Manager (OPSM). When defining products in OPSM, the Product Code, Product Code Type, and Product Code Variant are used to uniquely identify each product. This data will help determine the methodology and the data used in serial number creation.

The system will validate each product code as determined by the product code type to ensure that the product code complies with the type.

OPSM supports and delivers a few standard product code types (GTIN and NDC) but you can create additional product code types to meet your business requirements. OPSM delivers these predefined product code types:

• GTIN: The GTIN number identifies a particular class of objects, a product or SKU. The GTIN number by itself is not unique. All representations of a Serialized GTIN (SGTIN) support a full 14-digit GTIN format. The SGTIN number includes a GTIN number as one of the segments.

  • GTIN-14 Structure (14 digits)

    • Indicator (1 digit) - Optional element only used in the GTIN-14 data structure. It can be a value of 1-8 (9 is reserved for variable quantity items) and is used to indicate packaging levels.

    • GTIN (12 digits) - Contains either a GTIN-13 or GTIN-12. The GTIN itself can be unique or the indicator can be used to make the full GTIN-14 number unique.

      • GS 1 Company Prefix - Number allocated by the GS1 Member Organization. Comprised of 6-10 digits depending on the capacity needs of the company.

      • Item Reference - Number assigned by the owner of the GS1 Company prefix to identify the product.

    • Check digit (1 digit) - Calculated check digit number.

  • Format Example

    • GTIN-14 - 1.000037.000209.1

• National Drug Code (NDC) - Drug products in the United States are identified using a three-segment number, called the National Drug Code (NDC). It is a Universal Product Code identifier for human drugs. The FDA enters the full NDC number and the information submitted as part of the listing process into a database known as the Drug Registration and Listing system (DRLS). The segments of the NDC identify the manufacturer, the product, and the saleable unit package size.

  • NDC Structure

    • Labeler (4-5 digits) - Assigned to the firm by the FDA.

    • Product Code (3-4 digits) - Assigned by the firm to identify the product. The product code identifies the strength, dosage form, and formulation.

    • Package Code (1-2 digits) - Identifies the package size.

  • Format Examples

    • NDC442 - 0037-0209-01

    • NDC532 - 00037-209-01

    • NDC541 - 00037-0209-1

    • NDC542 - 00037-0209-01

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