no-bullwhip-supply-chain-management-blog

China Serialization Deadlines for 2012 National Essential Drug List & Webinar

Thu, 23 May 2013 05:00:00 GMT

China’s updated National Essential Drug Lists (NEDL) were published on March 15th, 2013 and came into force on May 1st 2013. The 2012 version of the NEDL includes 520 drug molecules on it, including 317 chemical drugs and biological products with 850 dosage forms. Oncology drugs, human insulin products and drugs for blood diseases are some of the new medicines added to the 2012 NEDL.

On May 9th, the China Food and Drug Administration (CFDA) announced the new drug serialization and traceability reporting deadlines for these added medicines. They include:

November 30, 2013: 2012 NEDL drug products that are domestically packaged (i.e. w/in China) need to be serialized and reported upon to the CFDA.
March 31, 2014: 2012 NEDL drug products that are packaged outside of China and imported into the country will need to be serialized and reported upon to the CFDA.

The new NEDL products, like the 2009 NEDL list drugs and the Provincial Essential Drug List medicines which have deadlines throughout 2013, all have similar requirements for acquiring serial numbers from the CFDA, applying the serial numbers at the case and unit package level and reporting on various commissioning and inventory movement transactions across the supply chain.

TraceLink and special guest David Colombo of Eli Lilly recently gave a detailed explanation of the deadlines and the operational and technical requirements for companies in the supply chain with respect to China serialization and traceability reporting compliance.

You can watch a streaming replay here: China Serialization Webinar

India Delays Primary-Level Barcoding for Exported Pharmaceuticals

Tue, 09 Apr 2013 05:00:00 GMT

The Director General of Foreign Trade (DGFT) in India has announced that India has deferred primary level (e.g. blister pack) barcoding for track and trace of exported pharmaceuticals one year to July 1, 2014. The original date of implementation for this requirement was to have been July 1, 2013.

This was the third phase of serialization and barcoding of pharmaceuticals manufactured/packaged in India and destined for export. The previous two phases for tertiary and secondary (unit or package) level serialization were implemented in 2012.

The DGFT described the change in the public notice no. 54(RE-2012) published on April 5th. Link to the notice. Navigate to the Public Notices section, Public Notices 2012-2013 and click on the link for notice 54(RE-2012)/ 2009-2014,

Brazil Proposes Pharmaceutical Serialization and Traceability System

Thu, 04 Apr 2013 22:06:00 GMT

Brazil has announced a new drug serialization and traceability system. The National System of Drug Control proposal published this week by ANVISA essentially provides for serialized drug identity and supply chain-wide drug traceability from production to dispensing where each node in the supply chain maintains their own database of product and transaction information.

The proposal has a 180-day implementation timeline for manufacturers and 1 year for the rest of the supply chain participants, to start upon publication of the final regulation. The proposal is now open for a 30 day comment period with final publication date to follow at some point thereafter.

Complete analysis of the serialization and traceability requirements is underway but below is an initial snapshot of the scope of the proposal.

Key Provisions

Serialization: Serialized identification on secondary packaging (and hospital packs), using a 2D DataMatrix, which includes ANVISA drug registration number, unique randomized serial number, lot number, expiration date. These combine to form the ANVISA Unique Identifier of Medicines (IUM).
Supply Chain Transactions: Tracing and capture of all product movements from point of manufacture to point of dispensation at pharmacy, including reverse logistics. Importation and transportation is also mentioned in the draft proposal although it is unclear exactly how these movements are to be captured.
Manufacturer: Maintain in a database the following information: IUM, identification number (CNPJ) of drug recipients, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
Distributor: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
Pharmacy: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
Data Archival: Two (2) years after the expiration date of the drug product

Note: Although the official document mentions serialization at the secondary packaging level, it also specifically defines that the Unique Identifier and Serial Number should be encoded on the smallest unit of product marketed in Brazil. So this implies item-level serialization.

Here is the official ANVISA announcement link.

GS1 Publishes 2015 Serialization, Pedigree Implementation Guideline

Mon, 11 Mar 2013 16:51:00 GMT

The GS1 Healthcare US Secure Supply Chain Task Force, the leading organization developing standards for pharmaceutical traceability and including more than 50 industry participants (including TraceLink), published on March 11, 2013 an initial implementation guideline for serialization and traceability of pharmaceutical products using GS1 identification numbers.

The guideline titled “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace”, is designed to help pharmaceutical companies and their supply chain partners prepare for upcoming state (California 2015) and potential federal regulations governing the serialization, ePedigree and traceability of drug products in the United States supply chain.

The guideline acts as a summary of current learnings from companies across the industry, providing an initial baseline to help companies design their systems and supply network preparation plans for compliance. The guideline includes information on:

Product serialization standards and identification concepts (GLNs, GTINs, SSCC identifiers)
Data carrier options for encoding GS1 information (Barcodes, RFID tags)
Supply chain data exchange for pedigree and traceability (EPCIS concepts, interoperability considerations)
Pilot learnings and best practices

Here is the link to the official announcement by GS1.

Here is the link to the Implementation Guideline by GS1.

California Board of Pharmacy E-Pedigree meeting (3/14) agenda

Fri, 08 Mar 2013 06:00:00 GMT

The California Board of Pharmacy has posted the agenda for the upcoming 3/14 meeting of the Enforcement Committee and Public Meeting on E-Pedigree.

E-Pedigree Agenda Topics

SNI: Update on proposed regulations to implement serialized numeric identifiers
Grandfathering: Update on proposed regulations for identifying drugs which may be shipped into CA after the Jan 1, 2015 deadline without serialization and ePedigree
50 percent calculations: Proposed regulations on calculating the 50 percent of products each manufacturer must serialize and ePedigree by Jan 1, 2015
Inference: Update from the Board on their proposal for regulations concerning the use of inference. Read our notes from the Feb. 2013 BoP meeting on Inference.
Drop Ship: Discussion on the use of drop shipments in the supply chain and their ePedigree requirements
Implementation Timelines: Presentations and questions from pharma supply chain participants on their readiness to meet the staggered implementation timeline as laid out in California state law
Certification Process: Discussion on the certification process to comply with the ePedigree law

TraceLink will be there capturing the discussion and providing a summary for our industry friends. Here is the link to the official PDF of the meeting and agenda.

NOTE: Our CA Board of Pharmacy LIVE Q&A webinar (3/20) will bring out many of the answers and discussions which went on at the meeting. So join us!

CA Board of Pharmacy Inference Mtg.

Thu, 07 Feb 2013 06:00:00 GMT

CA Board of Pharmacy Feb 2013 Mtg: Inference in Pharmaceutical Supply Chain Discussion

TraceLink was at the Feb 2013 meeting. The focus: discussions on potential rule-making for managing inference in the California ePedigree/serialization regulations.

Key takeaways:

BoP supports inference. Their stance was somewhat uncertain to this point
BoP continues to struggle with understanding the issue deeply enough to make “fair” rules
BoP will now take the lead in proposing rules (see below) but expects significant industry engagement to finish quickly
Look for March 14th in SoCal as a key date for discussion
The undertone in the room was that the BoP expects industry will meet the 1/1/15 deadline

Concerns raised:

BoP stated that the officially submitted comments (19 of them) have been helpful to the BoP in understanding the need and desire at a high level. Commentary around using GS1 standards, 2D barcodes, etc. was pretty common across many submissions. Key sticking points remain though:

Lack of deep knowledge by BoP on technical, data and business process issues
Recommendations on standard operating procedures (SOPs)
How to manage liability in the supply chain when inference breaks down

BoP voiced concern that it doesn’t feel it has enough insight on the above three issues to create fair rules that balance patient safety with operational efficiency. The BoP hoped that the industry would coalesce around a detailed set of rules on inference that the BoP could start with.

Inference proposal:

Virginia Herold is now taking up the banner. She proposed some “core elements” to use as a foundation for inference rules. These will be refined in the next few weeks and discussed in March. The highlights:

When homogenous cases are received from the manufacturer, identity can be inferred (case-item) as long as a business relationship exists between mfg and distributor
If case stays intact, it can be shipped straight through w/o opening
If case is broken, units must be scanned to validate the inference
This inference can continue through multiple hops
BUT, if inference is used, at some point in the supply chain, that inference must be validated by scanning the units. I.e. no units can go into a case and blindly pass all the way through the supply chain
There must be SOPs to remediate and correct any deficiencies found when the inference is validated after the case is open
Inference rules must handle both normal distribution paths as well as direct to pharmacy chain scenarios
Allocation of liability will need to be specifically defined if a problem in the inference chain is found farther down in the supply chain (i.e. pharmacy finds problem with unopened case)

Other key areas such as exception management weren't addressed by the board.

All in all...a pretty narrowly focused set of discussions.

CIOs Must Lead Cloud Initiatives

Tue, 24 Jul 2012 10:16:00 GMT

Every five to ten years there is a disruption to the Enterprise IT infrastructure which generates significant business value and undermines current operating models. Some of us are old enough to remember the introduction of desktops, ERP and the Web, technologies that eventually became indispensable in our daily business lives. Now CIOs have the next great opportunity to change the game for their companies with the Cloud. In working with companies large and small who are adopting the TraceLink Business Cloud, we recognized that CIOs need to be engaged in the definition and implementation of this new strategic direction.

At the heart of the transformation is the dramatic change it will have on IT spending. Gartner recently released its Worldwide IT Spending Forecast. Overall IT spending for the $3.5 Trillion industry is forecast to increase 3% in 2012. The table below also clearly demonstrates that in the current IT model, enterprise software is only 5.8% of expenditures. The software that runs the business requires significant ongoing investment in computing hardware, IT Services and Telecom infrastructure.

At the core, the Business Cloud represents an opportunity to transform the computing, application and collaboration model for how business is conducted. CIOs need to distinguish true Cloud solutions that utilize the global computing utility model, such as the TraceLink Business Cloud, from the rebranded SaaS providers that call themselves the “Private Cloud”. The economic and technical benefits of these “designed for the Cloud” applications are based on leveraging and enhancing the globally elastic computing utility model. The challenge for CIOs is moving the company in this direction while recognizing that current and future investments in their own or a business partner’s computing infrastructure will shrink. The Cloud provides such flexibility that CIOs no longer have to amass large, fixed IT budgets to deliver the capabilities that business owners require.

The next layer of value is the application deployment and delivery model. True Cloud applications for the business are always ready to use and quick to integrate. The new application model eliminates the need to spend years to configure, customize, integrate and deploy. Even the administration model is more user-driven and less centrally managed by IT. The model poses a challenge for IT departments and Systems Integrators whose budgets for a Cloud-based solution are 1/10th or less than that for a legacy on-premise approach. CIOs need to champion true Cloud applications even with resistance from internal departments and business partners whose interests are not fully aligned with the business opportunity for the company.

The final and most important strategic decision is to identify the unique solutions that define the Cloud initiative. Just as Web 2.0 was defined for consumers with collaborative applications such as Facebook, Twitter and Pinterest, business network collaboration will drive the innovative new value from the Business Cloud. For decades, enterprises have spent millions and in some cases a billion dollars establishing an ERP infrastructure to streamline internal processes. Today, however, business success is defined by how well you manage your extended business network, not just your internal operations. Yet “external collaboration” on this network is still driven by point-to-point email or portals that lack any cross-company or cross-function transactional collaboration capabilities. By driving supply chain collaboration through a Business Cloud, product, information and financial flows of the company become frictionless and adapt rapidly to market and operational changes. The best aspect of this strategy is that it greatly enhances the value of the ERP investments made over the last few decades by feeding these systems the network-wide data they need.

Gartner (http://www.gartner.com/technology/research/it-spending-forecast/) is predicting Public Cloud spending to grow at 18% a year which is 4 times the current spending growth projected by overall IT. The Public Cloud service market is expected to hit $200 Billion by 2016. This would put the market on par with the Enterprise Software market.

Once again CIOs are on the forefront of driving strategic value for the business with the Cloud. CIOs must lead this transformation since the status quo with their organizations and their IT business partners will be impacted.

NoBullWhip!

Microsoft SharePoint = Shared Disappointments

Tue, 13 Mar 2012 13:14:00 GMT

Let me first say that I like SharePoint. We use it here at TraceLink for internal document sharing and it works pretty well. Let me also say that it is an absolute failure for external collaboration. Time and time again we meet companies who were convinced to use SharePoint for external collaboration and the topic evokes very strong emotions. Everyone hates it! Yes, the emotions are that strong.

Our discussions are primarily with Quality, External Manufacturing, Contract Manufacturing and Contract Packaging organizations. The users were told that SharePoint would address the need to collaborate across companies for Batch Record Reviews, Events and Deviations, Change Control, Forecast Collaboration and many other supply chain processes between partner companies. The harsh reality of using SharePoint for these purposes is a loss of productivity and more error-prone processes at greater costs.

Here are the top 5 statements/feelings customers share about SharePoint:

“SharePoint is a Graveyard for Documents.” This statement cuts to the heart of the problem. It is not enough to just share documents, but users need to engage in shared supply chain processes. Right now documents are placed in folders and forgotten. Then there is the mess of trying to organize folders and versions of documents in a manner that aligns with the process state (“where am I in the Batch Record approval process and which are the right documents?”) as well as managing multiple processes (“which batches are still open for approval and which ones are historical”). Due to all of these issues documents go to SharePoint and die!

“SharePoint is a Nightmare to Manage.” No IT person wants the thankless job of managing the on-going security and administration issues created by SharePoint. It is a pointless effort to try to manage user access for individuals who are NOT your company’s employees. Not only do people join and leave your partner’s companies but the members of the teams are changing. So managing credentials and access control is a constant headache. Not to mention the issue of sending a physical security token to all the users at your partner companies. Security policies require these physical tokens to be accounted for on a quarterly or annual basis, requiring IT to verify that employees not at your company still need access to your SharePoint server. What an administrative nightmare!

“SharePoint is Less Productive than Email.” The main issue for business users is that they are working with multiple partners simultaneously. Every time they need to share documents they need to use a different security token and log into a different SharePoint server at the host partner company. As if that wasn’t bad enough, then file upload takes a very long time since the servers are hosted inside your partner’s firewall. This is the equivalent of logging into a different email system and waiting until the file arrives at their company server before you can “send” a document to the next company. Every person loses hours of valuable time every day!

“SharePoint is Expensive.” SharePoint has the same financial traps as most large client-server applications. While the base license seems reasonable, it is the tractor trailer that comes with it that drives the price way up. In order to deploy SharePoint for external collaboration an installation will need SQL Server database licenses, multiple servers to host the core system, additional servers for disaster recovery and even more servers for your partners to use outside of the core IT infrastructure. So not only are the base deployment costs high but the cash register keeps ringing because of the performance issues. SharePoint requires large recurring IT budgets!

“SharePoint Projects take Forever to Complete.” In order to address all the feature and architecture shortcomings there is now a sub-market of Value Added Resellers and Systems Integrators ready to deploy, customize and integrate SharePoint. These projects add to the cost and time to realize any value. Unfortunately most of these projects cannot produce the value sought by the users. SharePoint is just not the right starting point for meeting the user’s needs!

At TraceLink we took an approach to leverage the Cloud and create a solution for external collaboration that enables the supply chain to collaborate on processes within minutes with full security and exactly the functionality needed for the business. We provide live business processes, with team-based user management, a single login for all your external party collaboration, very-low subscription pricing and no customization or deployment costs required.

NoBullWhip!

Drug Shortages and Counterfeits Can Be Eliminated

Wed, 15 Feb 2012 20:12:00 GMT

In the last five years we have seen a very rapid growth in recalls and drug shortages. The ramifications are not only a lack of life saving drugs for patients but also a rise in drug prices and counterfeiting. The recent issues with Avastin counterfeits and Doxil supply shortages clearly indicate the problem is growing and becoming more life-threatening. The situation keeps getting worse and the root causes need to be understood and addressed.

In parallel, we have seen the biopharmaceutical supply chain undergo massive changes based upon a fundamental change in the business model and organizational structure. Historically, biopharmaceutical companies were predominantly vertically integrated where they owned their own active pharmaceutical ingredient and bulk product manufacturing plants as well as their own packaging plants. In recent years, however, supply has become globalized and production virtualized. This has rapidly created a significant increase in the inherent risk in the supply chain. Products can now be manufactured in stages from all over the world and through a network of complex relationships. While the manufacturing network has grown in complexity the global distribution network has substantially grown in volume. China, India, Brazil and Turkey are all major growth markets, however their distribution networks are inherently vulnerable to diversion and counterfeiting. The US and EU markets are also threatened by the larger global distribution market with the diversion of counterfeits through importation or distributors engaged in illegal practices.

In order to address the growing risks in the supply chain, biopharmaceutical companies need to maintain the oversight of and collaboration with manufacturing partner companies as if they were their own plants. Many urge even greater visibility and tracking since partner companies have to manage the needs of multiple customers simultaneously. Coordination and visibility across the entire production lifecycle, including visibility into production status, quality reviews, material availability and current inventory levels, are essential to maintain the supply of quality products to the market. From a distribution perspective, China, India, Brazil and Turkey are now requiring both serialization and track and trace of products. The goal is to empower the pharmacist, the clinician and even the patient with the tools to verify the authenticity of the product before dispensation or administration. The US and EU are also moving towards comprehensive adoption of serialization, track and trace with authentication.

At TraceLink, we are working with major biopharmaceutical companies to address the need for superior collaboration, visibility, track and trace in order to achieve the supply quality, capacity and integrity required by the industry. Our approach is to create tight collaboration between supply planning, quality, logistics and manufacturing across companies in order to deliver quality products on-time and in-full. Our track and trace solutions use emerging GS1 standards being adopted by almost all countries for ePedigree and authentication delivered either through enterprise integration or mobile solutions available to patients via iPhone, Android or SMS phones.

With rapid adoption of the solutions that the industry has been developing, we can eliminate drug shortages and counterfeits from our global supply chain.

Lead Change or be Left Behind

Wed, 20 Apr 2011 05:00:00 GMT

Most people know that I spend at least 60% of my time in the field with customers. For instance, this week I will be in the office on Monday and the rest of the week listening and working with customers to solve their problems. The source of all our innovation comes from customers. Many are fond of telling me when and where we thought of that specific feature or capability.

As I was reflecting on my past few weeks of fairly intense travel and interactions, it became clear to me that the pace, magnitude and criticality of change at our Pharma/Bio customers is accelerating. The reality of $267 Billion of product sales losing patent protection over the next 6 years has shifted from planning for the impact to executing on a strategy to lead the organizational changes at the company. One thing is certain; there are no magic bullets since there are no new blockbusters that will fill the large revenue holes.

In the last five years, there have been many strategies openly discussed and shared within the industry. Therefore there is no secret strategy that one company has as its secret sauce. The following press release, IMS Forecasts Global Pharmaceutical Market Growth of 5-8% Annually through 2014, indicates the approaches the industry will take for continued growth. These strategies include:

Growth from emerging markets
Personalized medications and complex therapies
Graduated approvals with on-going evidence of outcomes

The supply chain organizations are the most impacted by these changes, because they need to transform. A recent PwC report, Pharma 2020: Supplying the future, concluded by saying: “The supply chain is simultaneously becoming more important, as the medicines the industry makes get more complex and the opportunities for generating value from pure product offerings diminish”. These changes thrust the supply chain organizations into a strategic role within their company.

In all cases, the transformation of the supply chain involves driving more visibility and collaboration upstream all the way to raw materials suppliers, downstream to patients and across geographies into emerging markets. Here are some quotes from the field that demonstrate the imperatives:

“The company is banking on emerging markets for revenue growth and we need to ensure secure distribution”
“Emerging markets have 10x the counterfeiting and diversion and the trust factor is material to our revenue opportunity”
“Three out of five new product launches this year will be with products manufactured by outsourced providers”
“We need to track outcomes in order to enter the market and maintain FDA approvals for most new medicines”
“We want to be at the center of our virtual network and have all our partners connected to us with real-time visibility”

In the technology industry, we went through a similar stage for personal computers when the value of product innovation merged with the value of operational excellence. Dell and HP emerged as winners because they were able to combine product innovation with supply chain execution excellence. Change and transformation was not a matter of optimization but a necessity for survival.

Of the companies we work with, the ones that understand the moment are moving at a fast pace with determination that clearly sets them apart as leaders. They recognize that change is accelerating and Wall Street is very unforgiving of execution failures. Traditional and safe decisions are not acceptable when they don’t deliver the results necessary for the business. There is no buffer for mistakes or being a year behind.

At TraceLink, we are embracing the change and working with the industry to support their transformation. The velocity of the transformation will hit higher levels every day and we will be there with you delivering the visibility and collaboration your business needs.

NoBullWhip!

Customer Driven Innovation

Wed, 02 Feb 2011 06:00:00 GMT

Today we are officially launching version 2.0 of our Predictable Supply Network. Behind every company is a story of how it learns and evolves with the marketplace. As a company we always believe that the best ideas and needs are expressed by our customers. It is our job to listen, learn and collaborate with people that share our vision and partner in the development of the product.

The seeds of this release were planted more than a year ago when we first introduced our innovative Network approach to supply chain leaders. At every meeting, we had the same exact reaction. “Wow, we never thought of approaching the problem the way you have.” The fundamental value of a collaborative network of inter-operable business processes in an integrate-once and inter-operate with everyone framework was immediately evident.

However, the access and integration of the network into their current business applications and processes had to be automated. This is when you turn humble and let the customers chart your course. Our early partners, who include Catalent, Patheon, Sharp and a number of major pharmaceutical companies we cannot name, told us explicitly what we needed to do. They committed their time and a team to work with us to define and create the next set of capabilities.

The customer requirements were clearly expressed:

“We need integration into our ERP”
“We have multiple ERPs so we need to have an harmonization of the information formats for our systems”
“We want you to handle the mapping of the data to our supply chain partners”
“We want a solution that can allow us to integrate with all our partners without having to invest in individual integrations with each of our partners”
“We need to link the information across business processes including ones that are not supported by our ERP”

The commitment from our partners/customers included assigning teams to share information and actively work with us on the solution, as well as engaging in multi-day workshops with the executive team to identify and maximize the value for their business. As we designed the solution we iterated in a tight loop with teams across multiple companies. Our shared belief is that we are leading the industry to a new working model that will mutually benefit all parts of the supply chain.

With this release, we are not only providing the service to the larger marketplace to join in on our transformation of the supply chain platform, but we are also integrated with Catalent, Patheon and Sharp. This enables hundreds of Pharmaceutical and BioTech companies to now join in and seamlessly collaborate on Production Tracking, Material Tracking and Inventory Monitoring. With a single integration into the TraceLink Network these companies can inter-operate with any other company on the TraceLink Network. As part of the TraceLink Network, the integration is on your terms. Whether you want to integrate using SAP IDocs, EDI, XML or CSV, we have the support. Furthermore, you work with us to determine the formats you need and we will add the support.

This is a turning point for the industry and we are very grateful for the tremendous contributions by our partners. This process reinforced the values we operate with as a company.

NoBullWhip!

The Value of Multi-Enterprise Applications

Wed, 25 Aug 2010 05:00:00 GMT

In 2003, a few of us founded SupplyScape Corporation (the predecessor to TraceLink, Inc.) with a simple vision. We believed that the next wave of enterprise value generation was in integrating people, processes and information between companies. Our focus and core competency to the industry was to provide the integrative network for supporting the rapid selection and deployment of multi-enterprise applications. Today we express our mission as:

“TraceLink is Creating the Predictable Supply Network by Executing Any Business Process with Any Partner at Any Time.”

This month we announced our strategic partnership with Patheon, Inc. to promote supply optimization in Life Sciences. In our deep collaboration with the executive team at Patheon, we identified a number of immediate value propositions for Multi-Enterprise integration between contract partners and their customers. We have seen these core value propositions validated by every Pharmaceutical and Biotech company we are engaged with on building the Predictable Supply Network.

These value propositions can be classified into 5 areas:

Transactional Integration: This is the basic level of integration that allows for business documents representing inter-company transactions to be executed seamlessly. It is always surprising how hard it is to get large and small companies integrated into a common protocol and harmonized data sets to conduct business.
Data Synchronization: Beyond transactional documents there is a need to share information about process status, inventory disposition and goods flow between companies. Today teams on both sides are constantly generating reports from one system and sending it to the other company in order for it to be keyed into their system. Cost of labor and inaccuracies impacts execution and planning.
Synchronization Frequency: The use of manual processes limits the frequency at which information is exchanged. Monthly snapshots are the norm and weekly are the best one can envision. The ability to automate daily or event based synchronization of information provides both companies an advantage in managing demand and fulfillment. Predictability of supply has an immediate top line effect on revenue as well as a bottom-line effect on inventory costs.
Shared Visibility: Too often planners and production managers are looking at separate systems with different versions of the truth. With the TraceLink solution the network synchronizes the harmonized information into shared visibility that is available to teams from both companies. We are able to link and analyze the information and the application is shared between the companies.
Ad-hoc Collaboration: Teams need the ability to share documents and notes in order to efficiently execute in a dynamic marketplace. Each team we work with always has a need that cannot be adequately captured through a structured business process. Therefore they need to be able to exchange notes and documents representing instructions, documentation, artwork and many more pieces of information that cannot be categorized a priori.

In order to ease the adoption and maximize the value, we agreed to build an SAP Adapter to integrate SAP implementations with the TraceLink network. Patheon will work collaboratively with us to define and develop the SAP Adapter. This will be of significant value for the industry since SAP is the largest installed base of ERP implementations and the clear leader in the top 50 Pharmaceutical and Biotech companies.

The value propositions represented here are just the tip of the iceberg. In all our collaborations with the industry, we can easily identify more and more business process integrations that will drive higher and higher value. I compare where we are today with where SAP was 30 years ago. The initial value of SAP was to consolidate the information and reporting from a single general ledger. ERP was built from those roots.

The Predictable Supply Network is being built on these five foundational value propositions stemming from our Multi-Enterprise Application.

Functional Simplicity for What Matters

Mon, 21 Jun 2010 05:00:00 GMT

Today, we announced our strategic partnership with Catalent. Over the last six months we have learned significantly from each other and developed a clear understanding of the functionality and information that needs to be shared between a global contract manufacturer and packager with their thousand customers. Instead of getting distracted by the complexity of each relationship, we focused on functional simplicity and broad utility.

Companies have complex business processes and inter-company process integration is often a tug of war between two companies trying to force-fit one company’s process with another company. The semantics surrounding these conversations is also confusing, since business process names and information fields are interpreted differently by both parties. Expand the conversation to all your supply partners and you soon have a massive challenge in basic communication. The standards approach with EDI and proprietary portals only makes matters worse, because it requires too much process and information integration to get even the basic level of visibility.

In reality, we just need to use a single business application for processes that cut across all the supply chain companies. By using the same application that has a common definition of data, business rules and collaboration tools, we can eliminate the many-to-many, multi-enterprise issues. The purpose of a common application is not to supplant current business applications at each company but instead to put into a common application framework the processes we already conduct via our informal activities using fax, phone and email.

In any large-scale network application, the value is based on commonality of capabilities. Inter-operability and uniformity, enabling collaboration with all partners, is far more important than special features for specific members. Large-scale network applications focus on core features that enable valuable capabilities across all users. At the core, Facebook and LinkedIn are very simple applications that enable its users to connect and share information across a set of relationships.

Our approach at TraceLink was to focus on the core functionality needed to facilitate communication, coordination and collaboration for well understood business processes. In order to keep it simple and valuable for our customers we established three guiding principles for designing functionality in our service:

We are the communication vehicle between contract suppliers and their customers for their shared business processes.
We facilitate the shared execution of those business processes by enabling each party to push and pull information in a format and manner best for themselves.
We link and instrument the related business processes to show mutual dependencies and overall analytics.

These principles enable us to fill the capability gaps between companies without imposing one partner’s IT requirements on another. We believe our approach and solution will deliver the true benefits the industry seeks from a Cloud Supply Chain. Our partnership with Catalent will enable us to lead the adoption of a solution that will create a more predictable supply chain.

No BullWhip!

Empowering Business Users with Immediate Access

Thu, 27 May 2010 05:00:00 GMT

The industry is abuzz with Cloud and SaaS applications, but most of them take the same enterprise solution design and provide it in a new deployment model. A conventional application available in the Cloud still requires IT to configure and manage at significant time and cost. When we look at Web-based applications that truly transformed industries (such as Google and Salesforce.com) their approach was to design a new solution centered on providing immediate access of a service to a business user. By empowering an individual to use, learn and share experiences of a business service, we can eliminate the time and cost required from IT to deploy and manage solutions. Instead, we place the solution directly in the hands of the business users via a simple registration process.

Any individual or department leader can use Salesforce.com to manage a sales pipeline or customer service through a simple registration process and credit card payments. In 2000, my VP of Sales at our company came to my office to inform me that he had decided to use a new online sales management tool. Salesforce.com’s tag-line at that time was: “Just Sign-On”. Within a week all the sales people were productively using the sales automation tool. Today, Salesforce.com has over 51,000 customers and other software companies are using a similar solution design for many enterprise business processes.

At TraceLink we also broke the conventional supply chain application model by providing access to a shared workspace, business processes and partner management directly to the individuals that manage supply chain relationships. Anyone can execute any business process with any partner. In the end, we recognized that the people who need the solution everyday are both the best judge of applicability to their business problems and most effective at managing the adoption.

Furthermore, the people centered approach also enables an incremental adoption path for large organizations and complementary access to the smallest organizations. The benefit for constructing a Predictable Supply Network is that we can gracefully scale from the smallest company to the largest enterprise. The benefits of growing application functionality and no-cost of deployment are universally available to everyone on the network.

For a Predictable Supply Network to be effective, people need to be at the center of the solution, since it is their insight and experience which is the best judge for interpreting information. The network needs to support communication of their perspectives and instructions to all the relevant team members. The construction of the team itself can vary from collaboration to collaboration and the tools need to enable the individual team members to identify the appropriate individuals that are required from both companies to successfully manage supply chain operations.

By breaking the traditional model of IT-based application deployment and management, we put the controls directly in the hands of the business user. There can be concerns about overall policies and procedures and these can be addressed by providing management and IT with the tools to monitor and inspect usage for security and cost purposes. Therefore administrative functionality is available to observe the adherence of corporate rules.

Finally, complete traceability and accountability of all actions are available to all the team members. A self-policing team is a far more effective mechanism for compliance than instituting endlessly finer level of access controls. Complete visibility of all actions by users provides preventative protection which is cheaper to implement and maintain.

Empowering business users with immediate access is the first step in transforming the supply chain.

No BullWhip!

What can we learn from Google, LinkedIn...etc.?

Thu, 22 Apr 2010 05:00:00 GMT

At the heart of solving the fundamental challenges of managing a supply chain requires building a network for communicating and coordinating people, processes and information about product flow. All our visions of demand-driven virtues hit the friction-full realities of connecting people, processes and information flows. The time and cost to establish meaningful connections prevent widespread adoption, and the lack of predictability creates inherent loss of revenue, constraints on cash and greater expenses.

Today the industry is engaged in building connections using b2b links, trading hubs and portals. These approaches create many local proprietary solutions and don’t fundamentally address the many-to-many network problem. Each connection between partners becomes a major expense to establish and maintain. These costs limit deployments to some processes and some partners.

On a recent visit to a major BioPharma, they shared the time and costs involved in developing a portal for their contract partners. In the last two years, they spent greater than $3M dollars to develop a portal for one business process. To date, only one contract partner has agreed to use it. The following week, we had a meeting with a major contract service provider who indicated that they receive multiple requests for greater information and integration on a weekly basis. The contract service provider cannot jump from portal to portal for each customer nor can they service information requests in proprietary formats for each customer. What we need is an instant and common mechanism to establish collaborative processes with any partner at any time.

Our decades of experience in supply chain and technology combined with our very close relationship with companies and individuals provided us with a solid understanding of real world issues of production tracking, inventory visibility, partner management, distribution control and demand planning. To revolutionize the supply chain we needed to enable partners to establish secure collaborative workspaces, conduct shared business processes across companies, provide a common view of information within and across partnerships and empower people to manage the processes and teams independently.

At TraceLink we decided to look around and evaluate how large global networks are built on the World Wide Web. Google revolutionized advertising by building a massive network of advertisers and connecting them to content. Anyone can join that network with a credit card through a website. The value of Google is not just in the search engine but also in the advertising platform for the smallest to the largest businesses. In a New York Times article, the following growth of Google’s base was shared:

In a regulatory filing with the Securities and Exchange Commission, Google said it had 1 million advertisers as of 2007. If history is any guide, we can expect the number to be much higher now. The number of advertisers on Google has grown at a steady clip, from 89,000 in 2003, to 201,000 in 2004, 360,000 in 2005 and 600,000 in 2006.

The most impressive statistic was:

Interestingly, each advertiser, on average, spent a little more than $16,000 a year on Google. That figure changed little between 2003 and 2007.

In social networking, LinkedIn, Facebook and Twitter each established their own networks to enable information sharing and relationship building at unprecedented levels. These services established collaborative frameworks with information sharing, social process execution and sophisticated levels of permission management. The core concepts from these social networking giants establish a bold new path for inter-company business process execution and collaboration.

This analysis gave us new insight and ideas for how we can solve our supply chain challenges more effectively. Based on our lessons and understanding we established the:

Top Ten Tenets for Building a Predictable Supply Network:

People Network: put people not companies at the center
Functional Simplicity: provide only the most valuable capabilities
Shared Process: integrate processes across corporate boundaries
Connection Value: actively solicit connections to drive network effects
Long Tail: integrate and collaborate with all niches of partners
Be Discoverable: let people find you since it uncovers opportunity
Cloud Economics: share the cost and pay for only what you use
Self Managing Groups: let teams organize themselves based on their rules
Network Knowledge: leverage the information from all to make your decisions
Agile Adoption: start small, learn fast and grow quickly

These tenets establish a foundation for a supply chain leader to form a strategic direction and operational processes, which can rapidly grow the communication, coordination and collaboration with their partners. Our service intrinsically supports these tenets and enables rapid adoption. For instance, a user of our service can engage in collaborative production tracking with their contract partners in minutes after registering with our service.

In the coming weeks and months, we will discuss each of these tenets. Along the way we will identify the benefits and challenges in incorporating the Top Ten Tenets into your solutions and operations. Please share your ideas, issues and experiences so that we can learn from each other.

Together we will transform the supply chain. No BullWhip!