Monday, May 13, 2013

Pharma Industry: Anyone Experience Deja Vu when attending serialization conferences?

I have to first admit that I have not been in the serialization world nearly as long as some veterans of the industry...but it didn't take me long to realize that 95% of every serialization-related conference over the past 5+ years might as well be scripted....I've attended conference after conference, listening to the same 'user experiences' and hearing panel after panel tout the importance of getting executive stakeholders involved (is that ever not important?).  I will stop well-short of saying the conferences are not valuable - the opportunity to gather with industry peers and exchange ideas will always be a worthwhile activity....  But for someone who's perspective in this space has always been down at a detailed level the typical conference discussions are lacking.. even frustrating at times.

What sparked this topic for me was an article reviewing a recent conference (

DISCLAIMER:  My comments from this point forward are in no way critical of this article, the publication, or the conference it covered.  Rather this article, in my mind, highlights some of the misconceptions (and misunderstandings) still so prevalent in the industry.

#1 "On the heels of a Healthcare Packaging survey of more than 1,000 stakeholders that reveals one half of the respondents have not started a serialization project yet"
This comment is one more from curiosity as I am not familiar with the survey referenced in the quote.  My knee-jerk reaction was to be skeptical of the statement that half of respondents have not started a serialization project yet.  But as I thought about it more its only because we don't know the context of that statistic -

  • Is it half of Manufacturers?  (I'd actually find that hard to believe - but selfishly also hope it is true because I will be an even busier man than for the next year and half!!)  
  • Is it half of all supply chain participants?  (more believable).  
  • What constitutes a 'serialization project'?  strategy, pilot, implementation?   

I will continue to search for the raw results of the survey to get this context.

#2 "One speaker talked about the challenge of getting top management to agree that serialization is a regulatory necessity, not promising any ROI in the near future. "Meet with your C-level Suite executive individually and then collectively as a team to make sure all buy in.""
It cannot be denied that the majority of pharma, despite what's stated in project charters and strategic planning sessions, is being driven far and away by compliance- not by a desire to improve product security, or process efficiency, or supply chain visibility.  It's unfortunate, however, if this quote (in my interpretation) effectively says to give up hope of making a positive ROI anytime soon.  (See earlier posts about how other industries take on serialization and traceability with full expectations of achieving positive ROI)

#3 "While the vast majority of pharmaceutical companies use SAP, they need a bridge from another supplier to do e-pedigree. But one attendee said SAP is meeting to discuss what kind of module would be necessary to accomplish this. "Hey, if we are on SAP and our trading partner is on SAP, can’t you make it advantageous for both of us?"
I'm focusing mainly on the last sentence here - "Hey, if we are on SAP and our trading partner is on SAP, can’t you make it advantageous for both of us?".   For a technical guy like myself, and someone who advocates the use of standards, this just breaks my heart...  how often do we see the term 'interoperable' littered throughout pedigree and proposed federal legislation?  The whole purpose of EPCIS and DPMS is to ensure that any two systems, large or small, can communicate with each other.  This isn't a knock on SAP, it's a knock on the lack of understanding the underlying technical details of how serialization and traceability data, regardless of format, is traded between supply chain partners.

How interesting would it be to have a conference attended by the Solution Architects, DBAs, and Developers that have been deep in this space for so many years? Or better yet do we need to start sprinkling in sessions for these resource groups at the existing conferences?  I think it would be an eye opening experience...

Thursday, May 9, 2013

Traceability Tip of The Day: Determine Proper Ownership of Data in Your Serialization and Traceability Solution

Leverage best practices from Enterprise Integration to retain proper data ownership in your global serialization and traceability solution..... In most cases, the system to manage traceability data, often referred to (incorrectly) as an EPCIS repository, is being introduced for the first time to company’s enterprise IT architecture.  Whenever a new system is introduced, especially one that should be considered truly enterprise, two questions have to be asked:   
  1. What Data will this system own?
  2. What functionality will this system own?
Traceability systems introduce a new data set to enterprises which is the event-based information about activities that occur to their products.  In a GS1 standards-based solution this data is communicated in and, in many cases is known as, EPCIS.  In its purest form EPCIS is simply a bridge which connects key elements from other data-sets (i.e. product, location and others) together to create context-rich traceability information that is useful to business users.  A quick example - an EPCIS event may include an item identifier (SGTIN), a location identifier (GLN), and a business transaction identifier.  On their own these data elements are nothing more than strings of characters.  Additional data is needed to give the data context and meaning.  I group these different data sets into 3 categories (which will be expanded upon in future posts)
  1. Event Data  (i.e. EPCIS)
  2. Master Data  (i.e Products, Locations)
  3. Transactional Data (i.e. business transaction details, Lot details)
In almost all enterprise environments systems already exist which 'own' master and transactional data (such as ERP and other 'Systems of Record').  A dangerous path emerging however is to include significant amounts of master and transactional data into the EPCIS events directly.   My tip is to keep EPCIS for what it was intended to communicate - and leverage enterprise integration capabilities to push/pull/subscribe to master and transactional data feeds when needed.   This will result in less duplication of data across your enterprise and better defined data management.    Reach out to me to learn more about how to properly architect your serialization and traceability solutions.

Tuesday, May 7, 2013

The Dichotomy of Supply Chain Traceability

There are undoubtedly endless ways you can slice the concept of supply chain traceability into competing sides - feasible vs not achievable, valuable vs ineffective, strategic vs a pain-in-my-a**.  My experience has made me (or better yet, allowed me to) view traceability from 2 vantage points:

  • Those who must do it
  • Those who want to do it
Those who must do it vs those who want to do it.  I've written on this topic in the past - the fact pharma, by and large, is being regulated into traceability places a dark shadow over both its perceived value and the potential for implementing the absolute best solutions.  

I've had the unique experience in past roles to see both sides of this equation- sometimes in a matter of minutes.  I've held meetings with pharma companies looking ultimately for compliance and, quite frankly, wishing 'serialization' would just magically go away.

I then turned around and had meetings with non-pharma companies who couldn't implement traceability fast enough.  They recognized product security, process efficiency, and marketing benefits that ultimately elevated traceability to be a strategic driver for the company.

The drastic range in views always interested me -and honestly I can't say I know exactly why such opposite views exist, and thus I always return to the one obvious differentiator - regulation and compliance in pharma (i.e. being told what to do). 

Nonetheless, both sides can stand to learn from the other.  Pharma has championed the adoption of global standards- a critical component since traceability is really all about the sharing of data
Outside of pharma, however, I would often educate companies on this group known as 'G-S-1'.

On the other hand, outside of pharma companies are approaching traceability not as a supply chain capability but as their supply chain. Period.  And isn't that how it should be?  And to be clear these are companies that have just as complex packaging processes and global supply chains as pharma - in some cases you could argue even more complex when it involves tracking of upstream raw materials or components, as is often the case.  More folks in pharma need to be aware that traceability exists outside their industry and plenty of lessons can be learned.

The call to action for Pharma is to broaden the vision for traceability.  Embrace the fact that serialization and traceability are two independent concepts in which one isn't required in order to have the other.  Most pharma's use the terms 'Serialization' and 'EPedigree' to name their global programs but is that really inclusive enough?  I certainly can have traceability without serialization and without E-Pedigree.  Here's a litmus test - where does non-serialized item traceability fit into your global 'serialization' program?  A perfect starting point for an upcoming post.

Monday, May 6, 2013

Welcome to Jennason LLC - Let's Get Started...

It is with great excitement and pleasure that I announce the launch of Jennason LLC.   Jennason is focused on providing professional services to companies at all phases of product identification, serialization, and traceability initiatives.  Jennason is unique for one simple reason - the experience of actually doing serialization and traceability implementations for over 5 years.   It's a time of critical mass in the pharmaceutical industry as many have finalized 'pilots' of their packaging lines and distribution centers and have now reached the point where key questions arise:

  • How will all my IT systems 'talk' to each other?
  • How can I ensure I provide the traceability data needed to be compliant?
  • How is this all actually going to work?
Jennason's goal is to leverage past experience to help companies avoid the all-to-common pitfalls seen in serialization programs and instead design and implement solutions that meet the compliance requirements of today while laying the foundation for transformational supply chain capabilities of the future. 

Jennason is about acting and doing.   The phrase "The devil's in the details" is all too true when it comes to traceability solutions and that's exactly where Jennason can help.   From helping design some of the first enterprise serialization solutions to the pharmaceutical industry in the mid 2000s to bringing innovation and creativity to this space in the recent years Jennason's experience has always focused on the details.  

Even before this official launch the response from those in industry has been tremendous and I couldn't be more excited about getting things started.  For more information visit and reach out to me directly at        

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