Pharmaceutical Serialization Strategic Planning Guide
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Pharmaceutical Serialization Strategic Planning Guide

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Strategic planning guide to begin the serialization process and identify ROI and business value day 1. The best way to get value is to build it into the front end planning process. This take no ...

Strategic planning guide to begin the serialization process and identify ROI and business value day 1. The best way to get value is to build it into the front end planning process. This take no prisoners paint by numbers Guide should be the foundation for any pharmaceutical companies serialization planning strategy.

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Pharmaceutical Serialization Strategic Planning Guide Pharmaceutical Serialization Strategic Planning Guide Document Transcript

  • California 2015 Serialization & e-Pedigree:Strategic PlanningA Road Map to Compliance & Realizing Business ValueMichael StewartStrategic Business PlanningTrack & Trace ProjectsPharmTech, Inc.14048 Petronella DriveSuite 201Libertyville, IL 60048(847) 281-8924 direct(815) 403-8425 cellMStewart@PharmTechInc.com
  • Table of ContentsPreface – aka Mike’s Soap Box .................................................................................................................3Background ...............................................................................................................................................5California Serialization & e-Pedigree Requirements.................................................................................7Where do I start? ......................................................................................................................................8Infrastructure & Processes........................................................................................................................9Serialized Data Exchange ........................................................................................................................10Solutions Provider Assessments .............................................................................................................11Standardization.......................................................................................................................................12Identifying Business Value ......................................................................................................................13Business Value – Case 1 ......................................................................................................................14Business Value – Case 2 ......................................................................................................................15Conclusion...............................................................................................................................................16About PharmTech ...................................................................................................................................17About the Author: Michael Stewart........................................................................................................17
  • Preface – aka Mike’s Soap BoxThose that have heard me speak at industry events, private management workshops, or webinars knowthat I am always asking “What can we do better?” The “We” is you, the client, and PharmTech. The“What” is how you’re looking at your business and your project. It is what will turn this initiative, andany future project, from a sunk cost to a strategic investment.What I’m going to ask you to do in this strategy guide, written in a make-you-think cliff notes style, is tostep out of your comfort zone, especially when it comes to your mind set on business value. Includedare multiple questions that need to be thought through and answered and activities that need to beperformed, by internal staff or external resources. I will laundry list the various bullet pointed benefitsthat everyone proclaims from serialization to derive ROI and business value. While others talk aboutvalue in the ether, our engagements include actionable business value opportunities in our deliverables .What I want you to do is take a step back and instead of looking at this initiative as specifically acompliance project- a static, linear, regulatory challenge that has a beginning and end- I want you toview it as an opportunity. I want you to be possibility driven and accept the breadth and depth ofchoices out there.Learn to see business opportunities that are there for the taking, but hidden just around-the-corner.In this world there are two ways to view any situation that is perceived as difficult and requiressignificant thought, time and resources. You can view it as problem-minded or opportunity-minded.With a problem-minded approach, you see it as a static and linear issue that needs to be solved. Youbelieve that laser focus and getting to the end is doing the right thing, then cross it off the list. When youare opportunity-minded, you view the situation from a 360 degrees perspective rather than as a linearbeginning to end. You begin to embrace the possibility of more: more outcomes, more benefits andmore value.When you view situations in a linear perspective, a very straightforward, “this is what we need to do”, itis like a horse with blinders on. You and your team are so focused on trying to see and solve what youare trying to see and solve that at the end of the day you may have achieved the original end goal ordeliverable, but around you is a graveyard of opportunities missed. You win the battle and lose the warSerialization, e-Pedigree and product life cycle projects have cross functional opportunities that manytimes go missed because those involved do not see things in a 360 degrees perspective. They will missmore value opportunities than they see and the results will be less than they could or should be.You will see by a couple of the business value cases at the end, the mind shift for geometric revenuegrowth and additional business value outside of the initial compliance scope that was a byproduct ofserialization and traceability planning. I could have easily shown examples of the traditional benefitssuch as an internalization of serialization that led to a reduction in Days On Hand (DOH) inventory or
  • process efficiencies associated with applying GS1 standards to a pharmaceutical companies owninternal processes from ingredients and API’s to the distribution center workflow. That’s the easy stuff.I’m going to show you how a project deemed to be a sunk-cost (compliance) can become a strategicinvestment into the business that can drive millions in additional revenue and savings for your company.Take that laser focus, that blinders-on focus, and shine that light through this new business value prismto uncover all the hidden assets and hidden opportunities around this and future projects. There is littleto no additional cost involved in identifying these opportunities. All it takes is leadership and a shift frombeing problem-focused to opportunity-focused.With the immaturity in serialization in pharmaceuticals there are limited consulting and advisoryresources that have actually designed, planned, implemented and piloted traceability solutions,PharmTech just happens to be one that has. There are two problems with most consultants. First, ifthey are industry outsiders and journeymen, you are paying them to learn your business before they canever add value. Second, most bog you down in data and never provide action. They give information.They should give advice. You should be receiving “Here’s what to do about a situation” and “Here’sadditional opportunities we uncovered in the process to be addressed now or later as you see fit.” Thenthey should support it with facts. There is no benefit in giving you a data dump if you don’t know whatto do with it and why to do it.The role of a consultant is to provide leadership, thus allowing stakeholders to take the next steps.My role, and PharmTech’s role, is to connect the dots, to provide a road map and take you to the nextsteps while identifying additional opportunities and mitigating potential risks.God speed,Strategic Business Planning &Track & Trace Projects
  • BackgroundIn 2004, the California Board of Pharmacy passed legislation that required that all pharmaceutical supplychain parties, from manufacturer through pharmacy, be able to pass along an electronic pedigree thatwould detail the movement and transfer of ownership of a pharmaceutical product at the smallestsaleable item level.This mandate was to take effect January 1, 2007 and was later pushed back to 2009, then again to 2011over production line and technology concerns. In 2008, after convening with industry stakeholders, theCalifornia Legislature and the California Board of Pharmacy agreed to once again push back the effectivedate of the legislation to January 1, 2015.The pharmaceutical industry stakeholders involved unanimously agreed to accept the legislation with agraduated implementation between January 1, 2015 and July 1, 2017. The expectation was that thisadditional stay would allow the entire pharmaceutical supply chain (manufacturers, distributors,pharmacies) enough time to work through the design, pilot and rollout of an interoperable e-Pedigreesolution in the safest and most cost-effective way for all parties involved.The industry’s reaction and activities since the extension of the California mandates deadline for e-Pedigree compliance has been mixed. A few of the major pharmaceutical companies and the “Big 3”distributors (Cardinal Health, AmerisourceBergen, McKesson) took a leadership role and began planning,designing and piloting possible serialization and e-Pedigree solutions. Since there was no industryconsensus as to technology, standards, data carriers and capabilities downstream these have beenaccomplished with varied levels of success.Meanwhile, other industry participants have sat on the sidelines looking for either a mandate from theFDA requiring the same requirements as California or potentially usurping those requirements or havehad a wait-and-see position. Companies have chosen to wait for many reasons, but they boil down totwo. The first wait-and-see position derives from the idea that with the very real challenges inherent ina supply chain wide initiative such as serialization and e-Pedigree, that California may yet again pushback the deadline. A second position stems from the idea that “Pioneers get arrows.” This means thatthe first-movers, namely large Pharma, have the budget and resources to pilot and work through whatthe eventual solution would be. The companies that delayed decided they either could not afford or arenot willing to absorb these trial and error costs.Many other large and mid-sized pharmaceutical companies simply did not want to lay out the capitaland deploy resources for a large project such as serialization with legitimate concerns surrounding:• Extension of the California effective date beyond 2015• Uncertain technology• Immature market and lack of proven technical resources• Potential change to mandates by the FDA• Evolving ex-US serialization and authentication requirements
  • We are now less than three years away from the California serialization and e-Pedigree mandatescoming into effect. The wishful thinking around the mandates getting delayed again or a “silver bullet”plug-and-play solution to solve the technology interoperability concerns have not arrived. It is time forall stakeholders to develop their strategic business plan and road map to implementation for California2015 compliance.PharmTech, Inc. has been leading the Track & Trace conversation, planning and piloting solutions with atop 10 pharmaceutical manufacturer and others in the industry since 2007. In this strategic planningguide I will share our learning curve and provide the framework for internal team and managementconversations around developing the strategic business plan for your company serialization and e-Pedigree initiative.Due to the varied and evolving international mandates surrounding labeling, serialization,authentication, diversion and counterfeits, most pharmaceutical manufacturers have a handful of one-offs and independent packaging and tracking solutions out there to address the concerns of a specificmarket. What they have found is that this has become cumbersome and costly to the company andopens the doors to more problems than solutions long term. In light of developing a Californiaserialization and e-Pedigree solution, todays manufacturers are looking at a holistic solution that isseamlessly integrating both US and ex-US distribution.The PharmTech California 2015 Serialization Strategy Guide is designed to lead the conversation andincorporate more than just what solution providers to choose. When you look at a Track & Trace projectyou need to view it not as a compliance project. View this as the infancy stage of building what willbecome a legacy system within your organization that will deliver millions of dollars of tangible andintangible benefits and efficiencies to the company, the people and the processes.It is more manageable and prudent to plan and design a traceability system that can derive thesebenefits for the company and various functions within the organization when you plan for all the waysthat you can use this new data that is being generated, both internally and externally.For those manufacturers and distributors that have already installed a serialization and e-Pedigreesolution, this guide will provide value as a brief audit to ensure that the “i’s” have been dotted and the“t’s” have been crossed. In engagements where pharmaceutical companies have serialized their lines,PharmTech has then been brought in to develop the strategy behind “What can we do with thisinformation/solution to…increase revenue, improve adherence, gain dispenser loyalty, identifyefficiencies, etc…” There is value included here from those just starting strategy formulation anddefining requirements to those asking “How do we leverage the system we have?”
  • California Serialization & e-Pedigree RequirementsIn a very simplistic fashion, below are the highlights of the SB 1307 & SB 1476 California requirements.• Item level serialization at the smallest package level distributed by the manufacturer, receivedand distributed by the wholesaler and received by the pharmacy or final dispenser• Electronic pedigree, passed in interoperable format for each transaction of ownership change• 50% of a manufacturers products by Jan. 1, 2015• 100% of a manufacturers products by Jan. 1, 2016• Wholesalers and re-packagers must accept and forward products with e-Pedigree by July 1,2016• Pharmacy and pharmacy warehouses must accept and pass e-Pedigree by July 1, 2017• Penalties up to $5,000 per occurrence (each individual saleable unit is an occurrence)The amended California State Bill 1307 (8/20/2008) can be found at:ftp://leginfo.ca.gov/pub/07-08/bill/sen/sb_1301-1350/sb_1307_cfa_20080820_172325_sen_floor.htmlA summary with definitions of key terms for State Bill 1476 (defining e-Pedigree) is available at:http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdfAdditional material, including an extensive Q&A is available through the California Board of Pharmacysite at:http://www.pharmacy.ca.gov/about/e_pedigree_laws.shtmlFrom our experience, the largest challenge is not in the item level serialization component, rather inachieving interoperable data exchange and continuity among multiple ERP systems, trading partners,and business applications from the pharmaceutical manufacturer all the way downstream to thepharmacy/clinic, all the while maintaining 100% data integrity. If even one event or transaction ismissed, the entire chain of custody for that item/case/pallet has been compromised and broken even ifthere has been no diversion or foul play.
  • Where do I start?Great question, I’m glad you asked.In order to map how to get where you want to go, you have to know where you’re starting from.In taking that first step into developing your strategic business plan you must define your “as-is” state.These are the activities that highlight the existing infrastructure, product flow from manufacturing lineto final dispense and an understanding of how the company conducts business now and how thatstrategy or business model is expected to change going forward.Typical activities involve:• Process mapping• Gap analysis• Current/Future state evaluation• Business process analysis• Review of commercial relationships (contract manufacturing, contract packaging)• Analysis of market requirements, both US and ex-US• Impact analysis• Long term planning and forecastingWith a solid understanding of your base line it is time to move forward and compare the current state(as-is) to your future state (wish-to-be).By taking the time upfront to fully define the processes, movement and strategy of your company andproducts throughout the supply chain it is easier to more clearly identify business value opportunitiesthat exist and red circle the areas that changes or upgrades need to be made going forward.StrategyProcess MappingDocument Current StateCommercial RelationshipsGap AnalysisImpact AnalysisBudgetPlanningUser RequirementsFunctional RequirementsDevelop Use CasesTechnical ArchitectureDevelop Future StateBusiness Value PropositionsSolution Provider AssessmentImplementationInstallationStandards ConversionTrainingInternal Test & ValidationTrading Partner IntegrationPiloting
  • Infrastructure & ProcessesAn extensive review of the existing infrastructure and processes can create decision paths to guide theproject management and ensure that the correct path is chosen from start to finish.When evaluating infrastructure you want to consider not only the technological areas, but thoseassociated with manufacturing, packaging and distribution as well.An “as-is” versus “wish-to-be” infrastructure review should include discussion around;• Legacy Systemso Enterprise Resource Planning (ERP)o Manufacturing Execution Systems (MES)o Warehouse Management System (WMS)• New Hardwareo Packaging and Printing; line and off-lineo Edge deviceso Vision systemso RFID readers• New Softwareo Label management systemso Reports, alerts and dashboardso Policy based and user defined business ruleso EPCIS and central repository capabilitieso Serial number generation & managemento Business Intelligence tools (BI); current and future useo Business Activity Monitoring (BAM); current and future use• Implementation Strategyo Manufacturing line considerations (new or retrofit)o Line efficiency impact of serializationo System validation requirementso Hierarchyo Gatingo Aggregationo Master Data Management• Tactical Considerationso Exception handlingo User requirements & Functional requirementso Process WorkflowsA clear understanding of what your assets are and the processes that get your product manufactured,packaged and distributed is instrumental in order to identify where the gaps are that need to be filled.
  • Serialized Data ExchangeIn our experience, the line serialization, although a significant investment, is the less strategically taxingcomponent of the requirements. The larger challenge comes into play when you have multiple parties,internal and external, and multiple technology platforms, internal and external, that require theexchange of serialized data.After a review of your internal infrastructure capabilities and processes, your team is now ready to askthe questions that will help define the IT activities and needs.Examples of the questions that need to be addressed are:• Technologyo Does the technology team understand the standards (GS1 or other) that our systemsneed to support? Is it capable of supporting multiple standards until they are merged?o Has the technology team identified and coded internal and external product movementevents for EPCIS?o Should we avoid integrating with any existing systems because there are plans toreplace the existing legacy systems in the next 3-5 years (i.e. ERP, WMS, MES)?o How will we respond to e-Pedigree and supply chain queries?• Processeso What is our intent to aggregate product into hierarchies?o Will each hierarchy be with the same data carrier or will it vary by item, case & pallet?o How are exceptions to be managed internally? Externally?o Will our serial numbers be managed at a site level, enterprise level or global repository?Why?o How will we provision serial numbers? Will our serial numbers be randomized? Why?o What do we do with unused, yet distributed serial numbers?o How will we handle serial number commissioning, aggregation, disaggregation anddecommissioning reporting?• Relationshipso Have we identified all parties that we need to exchange serialized data with?o Have we decided how we would like to receive serialized data from trading partners,TPCM and TPCP?o Have our trading partners decided how they would like to receive serialized data?o How will data share and pedigree requirements differ between distribution options?o How will we manage differing customer requirements in serialization?As you can see, there is more to serialization than just generating a number and slapping a label on it.The greatest leg work is in defining what data is generated, where it is to be sent, how it will be used,how it will be sent, how it will be received and how all of this can be accomplished through multiple andvaried technological platforms.
  • Solutions Provider AssessmentsThere are two schools of thought when it comes to the assessment and selection of the solutionprovider(s) in serialization and e-Pedigree projects.The first is the “parade” approach. With this approach the stakeholders march in solution provider aftersolution provider early in the process to hear about how their wares will solve every imaginable businessproblem that the client has. After a few, they tend to blend together as they all say “We can do thattoo.” This is not a slight on any solution provider. It’s their sales process.Why this process is not effective is twofold. First, it is inefficient. It is a huge waste of time for thestakeholders and the solutions provider as neither knows in advance of the meeting if there is a fit giventhe value opportunities uncovered, markets that products are sold in, existing infrastructure, userrequirements, functional requirements, budgetary considerations etc… It’s an approach of throwingstuff at the wall and hoping something good sticks- by both parties. If the right things are said it leads tothe “silver bullet” mind set where one can be deluded into thinking there is one magic solution. Second,of course you will hear that the solution providers system can do anything you want; a) they have acaptive audience and b) they only have one arrow in their quiver (their solution).Perhaps I’m being a little hard on the providers. Let me retrace my steps. All of the providers availablehave excellent solutions. The difficulty is in ensuring they are a match based on what your specificcompany requires: capabilities, functionalities, cost considerations, impact to existing processes andtheir ability to deliver on existing and proposed strategic solutions that were defined in your earlystrategic business planning.The second approach is to bring in the solutions providers after the processes have been mapped,impact has been determined, requirements have been defined, and the company has had theopportunity, in advance, to vet and to compare and contrast the strengths and weaknesses of theavailable solution providers before they meet.As an example, PharmTech maintains an up to date proprietary Solution Provider Matrix for most of themainstream and upcoming serialization, manufacturing line, packaging line, middleware,coding/marking, vision, e-Pedigree and BAM/BI providers available. The Matrix provides a high-levelassessment of their strengths, weaknesses, costs, interoperability with various IT and businessapplications, service and support offerings, ideal client, sample of past engagements, and off-the-recordfeedback. It is an example of a tool that leverages the time and resources of the project and our industryexperience.Despite the marketing by many of the solution providers, there rarely is a case where a one-stop-shop isthe best choice when it comes to serialization and e-Pedigree, especially if the end solution is to addressboth US and ex-US mandates now or in the future. A combination of solution providers is usually themost beneficial. Performing this due diligence to ensure alignment with the strategic plan is crucial tothe success of the project and the company’s ability to leverage this infrastructure in the future.
  • StandardizationAlthough there is no required standard according to the California mandates or internationally, thepharmaceutical industry consensus is moving forward with GS1 as the standard of choice. Long theleading player in traceability within retail, GS1 standards allow for a uniform way to identify fixed data.Through the years, various pharmaceutical mergers and acquisitions and an ever expanding breakdownof product mix, has led to a substantial and growing mix of internal codes for product tracking purposes.Further complicating the matter is that these codes may vary by distributor, geographical market sold in,by packaging and by dosage just to name a few. GS1 standards harmonize this process by providing asingle reference that can be applied throughout the world.In PharmTech’s consulting engagements, it would be an understatement to say that those in theindustry have underestimated the sheer volume of work and time it will require to assign GS1identification numbers to product, places, trading partners, shipments and assets.Below are the foundational GS1 identification types1:• GTIN Global Trade Item Number Trade Item• SGTIN Serialized Trade Item Number Serialized Trade Item• GLN Global Location Number Locations and Trading Partners• SSCC Serial Shipping Container Code Logistics Unit• GIAI Global Individual Asset Identifier Individual Asset• GRAI Global Returnable Asset Identifier Returnable AssetsGS1 provides an international, cross-company, cross-industry and EDI qualifier standard.Questions to consider are:• Are we prepared for GS1 standardization and assigning serial numbers?o GS1 company prefix, data carriers selected, hierarchies defined• What resources are available to assign GTIN’s? How many will be required?• What resources are available to track down the physical and accurate addresses for everytrading partner, supplier and customer to assign GLN’s?• Will internal GLN’s be utilized for tracking of product movement from ingredients to dispense?• When do I need this completed since it represents the backbone of the end solution?1A detailed explanation of and applicable use for each GS1 identifier is beyond the scope of this paper. Additionalinformation can be found at the GS1.org website in the Resources section.
  • Identifying Business ValueIn the Background section it was mentioned that the serialization and e-Pedigree product traceabilitysolution should be viewed as more than just a compliance project and many pharmaceutical companieshave been less than motivated to embrace the implementation of track and trace solutions. That beingsaid, it would be naïve to miss the glaring reality that compliance is the current driver and motivation forundertaking these projects.Many Directors and VP’s within the industry embrace, as we do, that there are countless benefits tocome from serialization and the near real-time opportunity to view and dissect serialized productmovement data to capture business value, revenue enhancement and ROI. Even though the long termbusiness benefits to serialization have been proven in the retail, food and electronics industries over thepast 20 plus years, inclusion as a RFP (Request for Proposal) line item is mixed.As with any endeavor, adding business value as a talking point muddies the water and turns into aMissourian “Show me” debate that can derail the focus of getting the project funded.The initial activities outlined in the “Where do I start?” section, the mapping of workflow processesalong with internal and downstream product flow, will open the door for identification of whereadditional business value lies.Project highlights from past engagements will give you a flavor for how compliance became a secondarybenefit and real, tangible, financial benefits were identified and captured on our way to compliance.Below is a list of traditional advantages to a serialized product portfolio.The case studies that follow will show how a change in mindset from fixing a compliance problem toidentifying business opportunities can open doors to creating value including increased market shareand improved adherence just name a few. Brand Protection Identification of counterfeiting and diversion Recall management Asset visibility, tracking & utilization Reverse logistics Issue resolution and opportunities Real time response with BAM Pedigree and authentication capture Leverage captured data for improvements in;Sales & marketingInventory controlLogisticsWorkflow processesCash-to-Cash/Cash-to-OrderPerfect order
  • Business Value – Case 1With increasing costs of drug development, finding ways to boost market share of existing brandeddrugs which have gone off patent was of prime concern, as branded drugs have higher premium thancompeting generics.Challenge:• Flat sales and generic equivalents• Current system too costly• Need serialization compatibilityScope of Work:• System replacement• Item level serialization• Identify business valueResults:Serialization mitigated future regulatory concerns700 Clinic PilotAuthentication achievedCreated an automated software for the dispenser that provided,• Direct billing to Medicare• Automated inventory management reduces over-stock/under-stock• Dispense management system with patient and inventory interface• Automated patient scheduling• Direct Electronic Health Record (EHR) integration, HIPAA compliant• Reduced customer service staff 40% at the manufacturer3% increase in overall market shareExtensible to other products and divisionsAdditional Value Identified:During the initial strategic business planning PharmTech identified how the serialized data could bemanaged at the clinic level to generate efficiencies for the clinics patient management, automatedinventory replenishment and billing directly to Medicare to avoid missed billing reimbursement for thehealthcare provider. This led to a 3% “overall” increase in market share from just 30% of the distributionchannel and the signing up of 20 additional clinics due to the practice improvement software developed.
  • Business Value – Case 2Challenge:Manufacturer needed to serialize self-injectable for California compliance.Additional Value Identified:During the Product Life Cycle process mapping PharmTech identified that the manufacturer was losingopportunities in a self-injectable between Physician Recommendation & Decision Day (by patient) aswell as the time line between Prior Authorization (PA) & Benefit Verification (BV).Business Value Highlights;-Serialized the product line and piloted electronic data share of serialized information between partnersto ensure California serialization and e-Pedigree compliance-Provided web based education and financial assistance to patient to accelerate Decision Day choice-Integrated with EHR’s and Third Party Providers to remain HIPAA compliant-Opt-in at clinic level by patients for manufacturer provided education, third party marketing and pre-populated benefit forms for immediate benefit submission-Decision Day to Prior Authorization goes from an “endless loop” to 20 minutes rather than 3-4 weeks-Automated insurance Prior Authorization & Benefit Verification process reducing the decision from“Prior Authorization to Decline to Submission to Benefit Verification and Approval” from 30-60 days to72-96 hours-Increased clinic and patient adherencePhysicianRecommendationDecisionDayPatientPriorAuthorizationInsuranceDenialBenefitVerificationApprovalDeliveryAdherencePhysicianRecommendationDecisionDayPatientPriorAuthorizationInsuranceDenialBenefitVerificationApprovalDeliveryAdherence30-60 Day Cycle4-6 Day Cycle
  • ConclusionUndertaking or improving upon a serialization and e-Pedigree project is a daunting task. In order tocontinually move forward and avoid the many potential pitfalls along the way it is imperative that youand your team craft a road map to get you from the strategic business planning through the tacticalimplementation phase.Herein I have described the high level questioning and process analysis that can craft a strategy andprovide direction for your project. Like Alice in Wonderland’s rabbit-holes, answering one questionopens the door to many others.If you have the time, training, and resources on staff to complete the strategy and project managementof your serialization and traceability initiative I encourage you and your team to begin/continue thejourney towards compliance and identification of additional benefits. If, on the other hand, your teammay require the guidance and leadership of track & trace consulting professionals that understandpharmaceutical workflow processes, technology interoperability, regulatory packaging requirementsand can identify where the land mines are buried so you can avoid them, PharmTech or anotherseasoned firm would be happy to assist.One cautionary note, if you require serialization and e-Pedigree strategy or implementation projectmanagement leadership, the amount of experienced and qualified traceability consulting resources isslim and may dry up quickly as the mandates grow closer. Being proactive on contracting with aknowledgeable firm and gaining access to their resources that are familiar with traceability will ensurethat you will not have to settle for what is available with less qualified consultants.The clock is ticking and each day that passes is one day closer to the California mandates taking effect.We wish you well in obtaining compliance and identifying business value along the way.
  • About PharmTechPharmTech has a diverse 17 year background in Quality, IT, FDA compliance, manufacturing, workflow,distribution center management and supply chain. We are positioned to understand the entire productlife cycle, how California regulations impact operations, and how to identify business value in theprocesses to leverage the newly serialized infrastructure. The inclusion of business value into projects ishow we have always done business with our clients. This forward thinking leadership is the trait that is adifferentiator in PharmTech being selected for the pharmaceutical and biopharmaceutical projects weundertake.About the author: Michael StewartWith a background in investment banking and long term financial planning, Michaelbrings a unique perspective to the pharmaceutical industry. His approach of identifyingROI and business value in Track & Trace, serialization and Life Cycle Managementprojects turns these initiatives from a perceived cost into a strategic investment.Michael is a successful and entrepreneurial senior sales and business developmentexecutive with 18 years of experience in raising and deploying capital at regional andnational levels for established investment banks, major corporations, start-ups andconsulting organizations.Mr. Stewart is a regular guest and speaker at industry events, has delivered educational workshops,webinars to pharmaceutical executives and stakeholders, and authored white papers around topicsincluding; track & trace, supply chain optimization, pharmaceuticals, financial and sales & operations.Michael and the PharmTech team are available for speaking engagements, private thought leadershipworkshops, strategic business planning and project management for all areas of the product life cyclethat touches strategy, commercial opportunities, IT, manufacturing, packaging, supply chain and sales &marketing.You may contact Michael at:(847) 281-8924 direct(815) 403-8425 cellMStewart@PharmTechInc.com