In Part one we saw the basis around Serialization and the factors influencing the selecting the right software for one's serilaization requirement. Now in this post we will see some more important factors and begin with SAP solutions how it is fitting into all these factors.Lets roll on...
Regulations and Laws facing the Life Science Industry:
Counterfeiting and Drug trafficking are the major concerns facing the Life science industry and is a serious threat to the end users and the manufacturers too. Various countries in the world have realized their seriousness of preventing counterfeiting that they are coming out with new regulations and law enforcing all organizations involved in the supply chain to follow a standard way. In United States regulations are being made in the name of Pedigree and whereas in Europe it is made in the name of Packaging regulation or Track and Trace solutions .In Europe Turkey has already legalized their packaging regulation and hence by first of January 2009 all pharma products needs to serialized. All other countries in Europe are prepared to follow Turkey’s initiative. Considering all these facts it becomes imperative to select software that can cater to all the regulations be it pedigree or packaging or Track and Trace and would allow the organization to comply with all laws around the world. Though the deadlines of the regulations may vary from a country to country it is important from a healthcare organization to begin serialization initiative at least on a pilot scale so that they can meet the deadlines with much comfort and practice.
Global Standards and Industry practice for Serialization:
To prevent counterfeiting and drug trafficking it becomes important that the stake holders in the supply chain needs to exchange data between them. This exchange of data can be between organizations in the same country or locations in different nations of the world. All these leads to lot of questions on how and in what format the data should be exchanged between business partners. This is where GS1 steps in - a leading global organization dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. They had come out with global standard which most of the companies in the world are adhering to. They have come out with specific standards catering to the healthcare industry. They laid the guidelines for the Pedigree document that needs to be exchanged between supply chain partners which most of the US companies are following. GS1 standards are the most widely followed supply chain standard in the world. Considering the above facts in mind – the serialization software should be able to understand GS1 requirements and should support process to generate data in GS1 standards. By generating data as per GS1 specifications the organizations can not only work with their trading partners but with rest of the world who could be their potential business partners.
Now on having seen the factors that should be taken into account for selecting the serialization software, lets look at what Auto-ID solutions a serialization software from SAP cater to the market.
SAP solutions for Auto-ID and Item serialization :
SAP solutions for auto-ID and item serialization enable the use of radio frequency identification (RFID) to provide accurate, real-time information about items as they move through your supply chain and to automate your business processes. If organizations use barcode in their products the same SAP solutions can be very well be used. The latest versions of SAP solutions are flexible and have sufficient features in the product which can be used to support barcode though initially it was primarily designed for RFID.
Supported process and Functions:
SAP solutions for auto-ID and item serialization support the following business process in the industry:
Real time Business Process
Flexible Delivery Processing
Shipping and receiving meaning both Outbound and Inbound process
Generation of Pedigree Notifications
Generating Objects that can be used directly to generate Pedigree
Customer Returns processing
To Process the customer returns
Returnable transport Item Processing
For transport items that are returnable
Product Tracking and Authentication
For tracking and authenticating products
For tracking Events of your Products as they move across to your trading partner
A mechanism to interoperate with your trading partner
All these process are supported by the standard SAP Solution for auto-ID and Item serialization. However they are offered in two different names in the same umbrella namely Auto-ID Infrastructure and Auto-ID Enterprise.
SAP Auto-ID Infrastructure:
A local instance of the component SAP Auto-ID Infrastructure can monitor the flow of data and goods within your enterprise, and integrate it with an ERP system to automate outbound and inbound delivery processing. Basically it supports all the first five process in the table.
SAP Auto-ID Enterprise:
Multiple local instances of the component SAP AII connected to a component called SAP object event repository to collect data centrally from across your enterprise and from your business partners. You can use the repository to query, manage, and monitor your processes centrally. It supports the last three processes in the table.
Hope you find this information useful. In the final part of this series lets understand how these serialization offerings from SAP and its features fit in to various factors that the Life science domain demand out of the serialization infrastructure.