Through this series my objective is to provide an understanding or information for beginners from life science domain on various topics such as What is serialization, Reasons that are compelling for serialization, Regulations for Life sciences, Global standards for serializations, support for such standards in the market,factors that may influence selecting the right serialization software and how SAP's solution cater to the needs of serialization requirement.
Hope this series would me informative to you. In this series though my focus is on Life Science domain it can be related other domain as well.So lets begin the series by trying to understand serialization and some basics around it:
What is Serialization:
Serialization can be defined as the process by which each product in the supply chain would be assigned a unique number. Serialization would enable one to identify the manufacturer, the kind of product, the integrity of the product etc from the unique number assigned to a product in a global supply chain scenario.
Why is Serialization necessary:
In general by serializing your product your organization would able to take account of all the products that are being manufactured from your facility. One can easily manhandle the operations associated with it. It can help you to maintain your brand in the market.If you look at life science domain, Drug counterfeiting and diversions are huge patient safety issues driving serialization globally. Organizations around the world have felt the need of serializing the product as a means to prevent counterfeiting and drug trafficking from happening in complex supply chain scenario. Estimated to be a $30 billion problem for US retailers and US $50 billion world wide as estimated by WHO in 2006.
The Business benefits for serialization:
Most of the projects undertaken in organizations are funded by business and they need to understand the value and benefits out of a project to fund it. Hence it becomes important to understand the business benefits and values gained out of serializations. The business organizations while serializing their product, need to capture serial numbers at all levels of packaging hierarchy (each - case - pallet - carton). Capturing the serial numbers at all levels would enable them to track and trace what is inside each package and by maintaining the history of particular product as it passes through the supply chain one can always authenticate the products manufactured by them. By doing this business would able to not only maintain their brand value in the market but also gain insight to the real time data in the supply chain space. They would able to know the time taken for their products reach the retailers, or the time taken by one's transport vendor to deliver their products, real time data in case of some unforeseen errors. With these real time data the business can not only meet the regulations at their country but benefit by taking business decisions out of them. However the organization would require right serialization software that would enable them to accomplish the above said requirements.
Now let us understand while choosing the serialization what are the factors that should be considered.The following are the questions that one needs to answer before taking an informed decision on the serialization software:
What is the reason behind Serialization undertaking?
What are the business processes like Outbound, Inbound and Returns etc that should be supported by the serialization software?
What are the features I am looking for in my serial capturing software?
What is the roadmap for the serialization process especially for pharma companies who have facilities all over the world?
Being a Life Science or industry from any other domain – do one know the regulations and law facing the domain?
What are the global standards and regulations followed in the serialization and traceability process?
These questions would enable one to understand their requirements clearly. In addition to it would help them to choose the right software that would help them to solve
their current requirement and also cater to the forthcoming laws, regulations and Industry standards. By choosing the right software one need not keep spending for all new requirements as the regulations and law are enforced. Let’s look at the questions and the intention behind it in detail.
Reason behind serialization undertaking:
It plays a vital role in deciding about your serialization software. It can vary from being simplistic just like Stock management to specific requirements like Pedigree, Product Tracking and Authentication, Accurate inventory management, Product promotion etc. It is important not only to put down one's reason behind serialization clearly but also to keep their objectives in line with regulations and Industry standards as most of the regulation is going to be legalized around the globe.
Business Process to be supported:
The next important factor comes to the business process that should be supported by the serialization software.Let’s take an example of a manufacturer – in this case he has outbound shipments, Returns, Product recalls etc as some of their business process. In case of warehouse it there might be additional business process like inbound process apart from outbound and returns processes. One got to make sure the selected software understand all these process and able to communicate with your backend where your sales order, delivery and shipment are created.
Product supported features:
While selecting the software one got to make sure the selected software would be able to support all the features that the Supply chain industry would need in the long run. This is important in the current scenario as the supply chain is maturing and understanding the need of co-operation between trading partners in order to confirm to laws and regulations. The selected software should not only cater to your requirements but it should provide adequate ramp up facilities to meet the industry standards and access to trading partners thereby eliminating repeated investment on the software.
Distributed Landscape environment:
Business organizations that have facilities all over the world would either manufactures products at different locations or manage their warehouse in different nations. For such companies it is very much important to have roadmap how they are going to address the serialization for their company as a whole unit. For instance for product
tracking and authentication scenario – one needs to have central repository of data across their distributed landscape for all products in order to record all the actions in the supply chain with respect to their products. Once recorded in central repository they can access it to track and authenticate the product in question. They got to have roadmap how they are going to manage all their serial data across all locations and make use of them for business purpose. One of the business purposes gaining popularity is allowing your trading partners to hit your repository and verify the product they received. Considering the above points one should select software which would be interoperable with their trading partners by the standards followed by the industry.
Hope you find this information useful, we will continue in the next post....
