7 Ways Serialization Can Benefit Your Business in 2015

Posted by Jesse Fields

Dec 18, 2014 9:43:00 AM

The New Year brings with it new US federal serialization mandates (FDA: DQSA/DSCSA) which in turn starts the journey of implementing a more robust track and trace solution for the players in the life sciences industry. Even though the current regulations require tracking at the batch level, the need for end-to-end serialization is not far behind.

Meeting this new regulation can be looked at in two ways: 1) Only implementing a solution to meet compliance or 2) Implementing a solution that allows your company to extract valuable information from all of this new serialization data. The second option truly leverages the investment to one’s advantage. John DiPalo, CSO of Acsis Inc., notes "Government mandates calling for unit-level serialization are not optional. A byproduct of these mandates is the ability to better protect your brands as well as improve operational efficiencies by using this data at the operational level.”

Below is John’s list of seven benefits that serialization can afford your organization:

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Topics: Drug Supply Chain Security Act (DSCSA), Serialization Management

The Additional Benefits of an Enterprise Serialization Solution

Posted by John DiPalo

Aug 26, 2014 11:51:52 AM

Given the complex, multi-faceted nature of enterprises today, it's more important than ever to find a solution that offers the visibility and traceability needed to help you effectively track your product.  

Serialization isn’t a new concept and it has been used by companies in order to provide track-and-trace, verification and authentication capabilities needed to meet compliance mandates and ensure product security and safety.  However, today’s technology coupled with an increasing need for visibility and control throughout the supply network have led companies to search for a solution that allows serialization data to be fully integrated across their enterprise.  

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Topics: Serialization Management

The Future of Running Your Business

Posted by John DiPalo

Jul 24, 2014 2:19:52 PM

In today’s fast-moving world, more companies are making the decision to move non-core processes out from under their control, and they are utilizing outsourced manufacturing and distribution partners to build, package and move their products while they focus on the marketing, design and activities related to managing the brand. In this new mode of operations, companies are now asking questions like “What is important to running our global enterprise?” and “How do I maintain control in this new de-centralized world?”

Other major questions being addressed as companies make the transition from a linear supply chain model to a more network-based supply model are how to manage product quality, how to measure product velocity through the supply chain and how to incorporate anti-counterfeiting, anti-diversion and other brand protection initiatives into this new network model. The solutions that worked for the old supply chain model no longer work for today’s new supply network. As the number of partners participating in just one company’s extended supply network rise, the need for end-to-end supply chain visibility and control also needs to be integrated into the systems that manage these processes.

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Acsis Selected as SupplyChainBrain ‘2014 Great Supply Chain Partner’

Posted by Dana Franklin

Jul 10, 2014 10:41:41 AM

As the market leader for supply network visibility, brand protection and serialization solutions, we are proud to announce that SupplyChainBrain has selected Acsis, Inc. as a 2014 Great Supply Chain Partner. In its 12th year, the competition received thousands of nominations during the six-month online poll, in which supply chain professionals were asked to nominate vendors and service providers whose solutions have made a significant impact on their company’s efficiency, customer service and overall supply chain performance. Acsis will be featured in the July/August issue of SupplyChainBrain Magazine as a celebrated member of this year’s “Great Supply Chain Partners” list.
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Topics: Awards, Supply Network Visibility

Former Head of SAP America Named New Acsis CEO

Posted by Dana Franklin

Jun 17, 2014 2:31:50 PM

As the market leader for supply network visibility, brand protection and serialization solutions, we are proud to announce today that Jeremy Coote, a well-respected software executive, has been named the new CEO of Acsis Inc. Prior to accepting the position as CEO, Coote was on the Acsis Board for three years.

“Acsis is focused on providing solutions for the way manufacturers do business today in order to deliver products to market and protect and track those products. The old days of the supply chain network are dated – the Acsis solution suite provides visibility into Supply Networks. Given this evolution of market demands, there is no better person to lead Acsis than Jeremy,” said Ken Sawyer, Acsis board director, and managing director and founder of Saints Capital, the private equity investor in Acsis. Read More

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Gartner Supply Chain Executive Conference: Day 1

Posted by John DiPalo

May 21, 2014 2:45:16 PM

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Drug Supply Chain Security Act (DSCSA) Public Workshop

Posted by Dave Turner

May 20, 2014 10:01:05 AM

interoperabilityI recently attended the FDA public workshop on “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format” for the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27th 2013. Over 120 people participated in the public workshop including Manufacturers, Repackagers, Distributors, Dispensers, Industry Consultants and Solution Providers.  The purpose of the public workshop was:

  • To obtain information about current practices, research, and ideas on the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of drug product in which a change of ownership occurs.
  • To discuss the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey this information to the subsequent purchaser of a drug product and to facilitate the exchange of lot level data.

We broke out into discussion groups to provide feedback on several topics, and here are overviews of a few:

1.  A review of Transaction Information, Transaction History, and Transaction Statement as defined in the DSCSA to discover if there were any specific issues or challenges related to the information that will be exchanged or if there were any clarifications needed.   There were many issues brought up by each group including:

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Topics: Drug Supply Chain Security Act (DSCSA), Serialization Management

Why wait for a mandate? Three quick reasons to do serialization now

Posted by John DiPalo

Apr 15, 2014 10:52:14 AM

As people further understand the new federal legislation around track and trace, there seems to be some mixed messages around the implementation of the new law. Understanding the full impact of lot level reporting and determining when companies need to aggregate serialized item level data to the case are two areas that are hazy for many. There are a lot of different interpretations. Maybe it is time to take a look at the requirement to serialize product from a different perspective.  Look at the supply chain issues that companies face today. Are there opportunities to provide an ROI on the serialization investment while keeping an eye to the future in order to support compliance? 

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Acsis Launches Supply Chain Industry Blog

Posted by Dana Franklin

Apr 8, 2014 3:52:30 PM

As the the market leader for data capture, track and trace and enterprise serialization solutions, today we announced the Acsis Blog, a global forum for supply chain experts to collaborate and share industry expertise. Acsis brings 18 years of supply chain industry experience to the educational blog, and experienced professionals Neil Thall, John DiPalo and other Acsis experts will author articles and monitor the forum.  Acsis is recognized for providing solutions that help companies gain real-time visibility and control over products from raw materials through delivery to the consumer. Read more here.

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The Path to Serialization

Posted by John DiPalo

Mar 18, 2014 2:59:14 PM

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Topics: Enterprise Serialization, Drug Supply Chain Security Act (DSCSA)