mind your own business

seriALiZATion GeT on THe riGHT TrACK2013

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prepAre for CombATin an effort to combat counterfeiting, regulatory bodies all over the world are introducing new requirements for enabling tracking and authenti-cation of pharma and biotech products. primarily aimed at codification, serialization (internal and external tracking) and e-pedigree (external track-ing), the new requirements will have major impli-cations for manufacturers, distributors and retail-ers alike.

in many countries, such legislation has already been put into effect and by the end of 2013, the european medicine Agency (emA) will introduce serialization legislation, to which all life science businesses must comply by 2017.

Get on the right track – and start preparing for combat today.

A bLessinG in disGuisefew will question that serialization requirements serve a greater good: Combatting coun-terfeit is in every pharmaceutical company’s interest - for ethical and economic reasons. However, the imposement of yet another set of mandatory rules - and a short deadline for achieving compliance - is also costly and resource demanding and makes pharmaceutical manufacturing even more complex. even though compliance is of course a goal in itself, it’s money and efforts well spent to implement serialization – and it is for a number of other reasons:

Combat Counterfeit the chief advantage of applying serialization measures is also the fundamental driver behind the legislation: it combats counterfeit.

according to the World Health organization (WHo), counterfeit drugs account for 7-15 per-cent of all the medicines circulating in developed countries – and up to 25 percent in developing countries. it threatens the health and safety of the consumers, weakens national economies, emboldens criminal organizations and erode the respect for intellectual proporty rights.

When genuine products become more identifi-able, so do the fake ones. Counterfeit drugs are easily stopped at the point of sale, and when there are no money to be earned, the counter-feit business will become less and less attractive.the results are undeniable: billions of lives are saved and companies avoid counterfeit-related economic losses.

optimization of supply CHainapplying serialization technology and proce-dures will bring major business benefits, based on providing more accurate and timely track and trace information across the entire supply chain, including:

• improved demand, production and distribu-tion planning based on better understand-ing of supply chain dynamics across distribu-tion channels and markets

• improved inventory control across internal and external warehouses

• improved shell life management, reducing scrap

• improved and more cost effective recall management across the entire supply chain

proteCtion of brand value and integrityif your product is subject to counterfeit, your company’s image may be compromised.

anti-counterfeiting becomes an ethical dif-ferentiator, as consumers expect companies to take responsibility for combatting fake drugs. protection of your commercial product by means of anti-counterfeit thus also protects your brand value.

improvement of sales planning and foreCastan effective serialization system can improve your ability to predict sales developments and make more precise sales forecasts. the serializa-tion system, in parallel to it’s prime purpose, can also work as a “early warning system” that can help you optimize e.g. sales campaigns.

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An end-To-end seriALiZATion soLuTionnne pharmaplan and nnit have joined forces to offer consulting and engineering services cover-ing all aspects of serialization, from packaging to the point of dispense.

together we will take turnkey responsibility for your serialization project, and we will stay at your packaging site until the serialization solution works perfectly and you have reached your oee target.

both nnit and nne pharmaplan have an insid-ers’ understanding of pharma and biotech pro-duction and are highly experienced in working with large complex systems such as sap object event repository (oer) as well as other sap

modules supporting the supply chain. We can run projects from consulting through implemen-tation to on-going support, leveraging proven methodologies and adhering to superior quality standards.

We work based on a proven model which provides an effective method for structuring a serialization project with minimal business risk for the customer.

Emerging legislation

Established legislation

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seriALiZATionLAndsCApeThe concept of serialization is the same globally, but the scope and status of requirements differ from region to region.

souTH KoreA

background: ministry of Health and Welfare notification 2011 – 58.

Timeline: January 2013Timeline aggregation: January 2015 Technology: gs1 standard. data matrix and linear

code gs1-128based on: unit level: Kd codesales level: Kd code, exp and lotshipping level: aggregationdata scope: Kd code (sgtin), expiry date, lot num-

ber, s/n and ssCC codes are mentioned

CHinA

background: sfda, april 9, 2008. mandatory for 275 edl (essential drug list) therapeutic classes.

Timeline: december 2012 edl expanded with +800 classes by 2015 letter from the sfda department of drug safety & supervision will be issued with a two week response period and six months implementation period.

technology: special 128c codebased on: Chinese developed authentication code.

piats (product identification, authentication and tracking system

sales level: yesshipping level: yes, aggregation neededdata scope: CnmC (China national medical Code),

s/n and encryption code

misCeLLAnous

Algeria: no regulations, no drafts but authorities are very positive about the eu modelbelgium: sequential stickersus: dod (dept. of defense) rfid, track & trace, inventory management in focusfrance: vignette stickers and Cip13egypt: no regulations, no drafts but authorities are very positive about the eu modelGreece: eof (national organization for medicines authenti-

cation stickersGermany: pilot in Q1 2013, national law italy: bollini authentication stickers. drift towards replace-

ment with 2d.spain: 2006, article 87 exist but the royal decree

is still in draft. Code pdf 417. rfid consideredJapan: special rules for special drugs regarding static

and dynamic data in code format. no s/n however.serbia: stickers solution has been postponed russia: no regulations, no drafts but authorities are very

positive about the eu model

eu

background: July 1, 2011 of the eu falsified medicines directive (fmd) implemented throughout 2014 – 2017. each member state to plan minimum requirements. each member state can act earlier when readiness has been established. each member state can add requirements (blue box principle)

Technology: gs1 data matrix / ean-13based on: gs1 standardsitem level: gtin (minimum)sales level: gtin (minimum)data scope: gtin-14, lot number, expiry date and

s/n was part of prior version of tender demands but has been taken out “technical guidance regarding identifica-tion key, may 17, 2011, version 2

indiA

background: directorate general of foreign trade dgft publiC notiCe no.21/(re 2010)/2009-14, october 1, 2011. export pharmaceuticals only. likely to be expanded to import also but no deadline. delays and lawsuits are rumbling. Will hit low cost generics manufactured in india hard.

Technology: gs1 2d data matrix or gs1-128 1d linear

based on: unit level: gtin, lot, exp and s/n, January 2013sales level: gtin, lot, exp and s/n, January 2013 shipping level: gtin, lot, exp and s/n, July 2012 data scope: gtin, lot, exp and s/n on all levels

track & trace mandatory

TurKey

background: phase 1, 2009: mass serialization phase 2, 2011: full aggregation original purpose to stop

reimbursement fraud and taxation avoidance

Technology: gs1 data matrix or gs1-128 linearbased on: unit level: nosales level: gtin, exp, lot and s/nshipping level: yes. aggregation neededdata scope: gtin, exp, lot, s/n and ssCC database owned by turkish health

authorities.

AfriCA

background: Counterfeit products on the african continent. tender and purchasing requirements stated trough relief organizations and agenesis (WHo, msf, red Cross/ Crescent and similar). used since 2005/07 with very positive result. expanded use to be anticipated.

Technology: simple numerical sms code Can be supplemented by aidC’s

(automatic identification and data capture) Hidden (tamper proofed) by means of multilayer or “scratch lottery ticket”

based on: unique numbers readable for humansdata scope: a serial number for verification by sms

brAZiL

background: anvisa, brazil law n° 11.903Timeline: January 2012

since “special security” label have been abandoned, there has been a drift towards the turkish model.

Technology: gs1 data matrix. tamper evident (label / hot melt)

based on: unit level: no sales level: gs1 data matrixshipping level: tracking likely to be implemented

according to turkish model data scope: gtin, ium (unique identifier for medi-

cines), drug registration number, product lot number, expiration date

ArGenTinA

background: anmat official bulletin #32.160, regulation 3683/2011. resolution 435/2011

Timeline: June 15, 2011 – June 15, 2012 for specific apis

Technology: gs1 data matrix / gs1-128 linear / rfid. tamper evident labeling and visual codes on labels.

based on: item level: no sales level: gs1 data matrix with gtin and s/nshipping level: rfid on shipper boxes and pallets

are preferred. data matrix not banned.

data scope: gtin (global trade item number), gln (global trade location number) optional but recommended, s/n (serial number) batch number and expiry date are optional but there must be a link between s/n and lot/exp.

CALiforniA

background: California business and profession Code section 4034 – 4169

pedigree requirements goes all the way back to 1987 and is mandatory in many states. However it’s only in a paper based hard copy version and from when shipments enter the us

Timeline: January 1, 2015 – July 1, 2017Technology: not definedbased on: not defineddata scope: full pedigree in an electronic format

(epedigree) from the original manufac-turing site/line source name, registration number (ndC), address, drug name, quantity, dosage form and strength, date of trans-action, sales imvoice number, container size, number of containers, expiry date, lot number, unique identification num-ber. business name, registration number, addresses and certifying person’s name and address. Certification that information is true and accurate.

us overALL

background: prediCt database run by diop (division of import operations & policy)

sni guideline march 2010 osd guideline gdp guideline

rx tec delegated act tracking guideline (upcoming) fda will adapt the same angle as euTechnology: upC-a or ean-13based on: unit level: ndC code sales level: ndC codeshipping level: ndC codedata scope: national drug Code (static id code of drug similar to gtin)

denmArK

background: amgros (danish purchasing association for hospitals and clinics). “demands on barcodes for tendering 2013 and expected demands for 2014 and 2015”, may 8, 2012. minimum tender and purchasing demands 2014-2015 are subject to changes.

Technology: gs1 data matrix / ean-13based on: gs1 standardsitem level: gtin (minimum)sales level: gtin (minimum)data scope: gtin-14, lot number, expiry date and

s/n was part of prior version of tender demands but has been taken out “technical guidance regarding identifica-tion key, may 17, 2011, version 2”

CAnAdA

background: Canadian pharmaceutical bar coding project. Joint technical statement v002. february 24, 2012

Timeline: phase 1: January 2008, phase 2: april, 2009, phase 3: 2010, phase 4: december 2012 – december 2017

Technology: gs1 data matrix / gs1 linear / rfid (as supplement)

based on: gs1 standardsitem level: gtin (minimum)sales level: gtin (minimum)shipping level: gtin, lot number, expiry date (minimum)pallet level: gtin (minimum)data scope: gtin, lot number, expiry date, no s/n but

can appear . if end user (hospitals and clinics) wishes. the same goes for rfid.

stated trough purchasing tender require-ments (similar to amgros)

5

THe suppLy CHAin LAndsCApe

A mAnufACTurer1. production of medicine2. application of umi to second-

ary packaging3. Case packing4. pallet packing5. decommissioning umis6. shipping umis

i AuTHoriTies & CusTom offiCers1. umis verification by inspectors

or customs2. batch recall report

mediCines verifiCATion reposiTory

AuTHenTiCATe number

upLoAd number

H pATienTs1. verifying umis

by mobile phone2. verifying umis

through a call center

3. verifying umis on the internet

4. verifying umis in a retail pharmacy

b disTribuTion Hub1. verifying umis at goods receipt2. shipping umis

C wHoLesALer1. decomissioning umis2. re-packaging

d re-pACKAGers1. decomissioning umis2. re-packaging

e inTerneT pHArmACies1. verifying umis

of goods receipt2. dispensing umis3. decomissioning umis

f HospiTAL pHArmACies1. dispensing umis

of goods receipt2. decomissioning umis

G reTAiL pHArmACies1. verifying umis

at goods receipt2. dispensing umis3. decomissioning umis

A 360º ApproACH To seriALiZATion

J mAnufACTurers pACKAGinG Line 1. serialization and tamper evident packaging

of sales units2. sales unit3. bundle4. shipper box5. pallet

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serialization affects all steps on your product’s way from the manufacturing line to the patient. Hence, you need to take a 360 look at your production, packaging and distribution when developing and implementing your chosen serialisation technology.

nne pharmaplan offers full circle support and we have the skills and resourc-es needed to guide you smoothly and effectively through the multi-faceted serialization challenges that arise in early planning and throughout the imple-mentation project.

We can help you improve your business case by priori-tizing and coordinating local and functional inputs, e.g. by balancing regulatory requirements with technological wishes and possibilities and market requirements.

We are familiar with the critical interfaces between the various scientific and functional aspects and know how to balance them to reach the most opti-mum solution, which accommodates relevant regulatory requirements and market and technology demands. ultimately, this means increased control-lability and efficiency and minimized risk for you.

orGAnisATionAL CHAnGe mAnAGemenTensuring cross-organisational awareness, understanding, capabilities and commitment• project kick-off and milestone reassessment• project communication• design effective organizational setup

and procedures• design and implement tools • build new competences and

understanding - training

A

b

C de f

G

i

J

H

umi: unique medicine identifier

benefiT reALiZATionaligning serialization effort with strategic intend and other business initiativesbuild and manage business case and benefit realization plan• identify and prioritize business drivers

and requirements• oee baseline and improvement plan• prioritize and coordinate activities,

resources and deliverables across projects, sites and functions

• programme management

fACiLiTy desiGn specifying, selecting, implementing packaging lines• Conceptual design• equipment specification• vendor management and

communication• design for oee

suppLy CHAin mAnAGemenTanalysing, designing and implementing logistics• product supply chain analysis• Contract manufacturing assessment

and management• Cold chain, logistics and warehousing

AuTomATion & iTidentifying, developing, validating and implementing robust it & automation systems• manufacturing information systems• pls/sCada• system interfaces• serialization software configuration• vendor management

and communication• project management

Gxp CompLiAnCeensuring right level of gxp compliance, balancing risk, flexibility and efficiency• risk assessment• test plans• validation documentation• sops

CosT eLemenTs

sCAdA / pCs / pLC integration

organisational change management

program & project management

business case developmentcommunication

vendor management

oee/optimization performance

warehouse solution

master data management

Training

systems integration

Cmo implementation

other

erp implementation systems interface implementation

verification & validation

serialization systemimplementation

packaging line equipment modification

sop development

improve

solution price range per line eur

fully integrated with erp

500.000 – 1.500.000

serialization + aggregation

200.000 – 700.000

serialization 50.000 – 300.000

40%

40%

20%

Typical cost distributionCorp site line

seriALiZATion sofTwAre• Configuration• Communication with vendor• interfaces• systech expertise

8 9

undersTAnd• regulatory status (serialization, gdp, pedigree, codification, etc.)• best practise in pharma industry• Communication• stakeholder management (corporate, sites,

Cmo, partners, suppliers, customers)

firsT depLoymenT• pilot production• live test of roll out approach

roLL ouT• local interpretation of global implementation script• installation• sat/iQ/oQ• pQ• oee optimization• training• securing harvest of benefits• setup of regulatory maintenance

Assess• Checklist-based assessment• regulatory requirements• product and market overview• analysis of requirements vs. capability of processes• supply chain overview• it & automation strategy• alignment with other intitiaves (corporate/sites/ partnerships)• stakeholder engagement

pLAn• roll-out master plan (including change management approach)• business case including benefits,

risks and budget estimation (+/-20%)• recommendations (technology, project organization,

vendors, compliance, turnkey vs. individual site implementation, etc.)

sCope• execution model• time schedule• team set-up• pre-budget (+/-30%)• opportunities for business benefits• business case (key figures from industry)• risk (prioritized)• alignment with other initiatives

from CorporATe LeveL

WHo does WHat

To siTe LeveL To pACKAGinG Line / wAre House

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initiate – 1 month

What is the scope and consequences of the new regulations, and how do they correlate to other changes and develop-ments in production, planning, supply chain management, it, sales and marketing, etc., which take place concurrently?

How can I take advantage of the demanded changes to implement other changes?a demand for changes can often be exploited to make other, op-tional changes, which can potentially bring huge business benefits. such changes could entail late stage customization, oursourcing to contract manufacturers, exchange or upgrade of technology or processes and streamlining of production flow related to change-overs, release, sampling, etc.

What is the business case, and what are the risks?typically, there is a lot of insecurity in relation to the financial im-plications and risks associated with new requirements. What is the invesment level?, how does it influence operational results?, and what are the risk factors involved in making the necessary changes? all those questions are essential in building a solid business case.

analyse – 1-3 months

Is it necessary to re-assess the product portfolio in light of the added costs and new opportunities/requirements for changes in package format and design?you may encounter challenges in terms of product profitability on e.g. small product series for small markets. you need to make an assessment of whether that should lead to changes in your product portfolio.

What are the specific implications for the product flow from API production through packaging lines and supply chain to end-distributor on the different markets?you have to identify which packaging lines, etc. are to supply which markets at which volumes – and thereby determine the required technology level for each line.

What is the level of technology readiness of my packaing lines and IT systems (ERP and MES) and in my supply chain? Does anything require change/upgrade/replacement/development?you need a clear assessment of the scope of changes that need to be developed and implemented in order to proceed.

execute - 6-8 months

How do i implement changes and improvements to my packaging lines, in my supply chain and at my Cmos and still keep my obligations to deliver? And how do i make sure i take full advantage of planned shutdowns and maintance periods?

How do I ensure that authority approvals are in sync with the changes in production and package design, so that the number of variants and the capital tied up in stock are minimized?if you’re dealing with different approval levels in different markets, the number of new products variants can grow quickly, creating a need for larger safety stock. this concern must be addressed.

How do I ensure effective implementation of new proce-dures, processes and technology on the factory floor with minimal reduction of OEE?the required changes may have significant concequences for work flow and work procedures, which all factory staff, QC and Qa people, etc. have to understand and comply with.

desiGn• global implementation script (templates, policies, change,

checklist)• detailed design• fat • training setup (global, local)• shipment• gmp• global erp/mes • risk approach• pre-installation• regulatory (registration)

ALL for oneto successfully implement a serialization concept – mitigating risks and leveraging possibilities – it requires careful investigation into a number of external and internal issues. from early planning and throughout the en-tire implementation process, there are important aspects which require scrutinizing, and this requires involvement from practically all divisions of your organization.

in this section, we highlight the key questions that companies need to ask themselves when converting their processes and business to new requirements. our approach to executing serialization projects are based on a model containing three phases, and we have identified the most critical questions in each of the phases.

for every project phase, we make available expert resources that will ensure successful completion. Hence, we can jump in whenever and wherever you need assistance. We can put together the ideal project team, whether we supply resources for the entire team or supplement your own resources.

manufacturer

Task

nne pharmaplan & nniT

equipment vendor

system vendor

readiness assessment

X

(X)

project management

X

X

automation solution

X

(X)

Commissioning and go-live

(X)

X

urs

X

line integration

X

X

Qualification

X

(X)

X

org. imple-mentation

X

solution design (Cd,bd,dd)

X

X

X

10

referenCes

A pACKAGe soLuTion

firsT in Line

establishing a serialization pilot line to pioneer for global application

our customer offers a wide range of healthcare products within pharmaceuticals, vaccines and diag-nostics, generics and consumer health to patients all over the world.

With patient safety at top of mind, the customer is putting much effort and many resources into apply-ing anti-counterfeit and product authentication measurements into their production machinery.in october 2012, the company reached a major mile-stone, when they completed the upgrade of the first packaging line to comply with the us epedigree

faCtboX

automation/it serviCes:• defining interface between serialization

system and existing automation and it systems• Writing conceptual design for local site

serialization solutions• Writing urs/blue print for corporate and local

site serialization system to be implemented• rollout planning • Creation of local and central staffing plans

for analyze and execute phases• Calculation of serialization solution price• screening and selection of serialization

solution vendors • implementation and validation of warehouse

solution• assistance to corporate serialization team

in local site implementation at packaging line• detailed implementation planning including

critical shutdown period• implementation of tamper evidence on

secondary packaging material in parallel with serialization implementation

proCurement serviCes• procurement management of serialization

equipment to local manufacturing sites• procurement management of corporate

serialization solution• negotiation of price and contract with vendors

validation serviCes:• preparation of validation master plan• validation planning• Control corporate and local Cr cases• Writing of overall solution urs

requirements for serialization and aggregation. the upgraded packaging line – which is placed in the customer’s key pharmaceutical plant – is to work as a pilot line for testing the new serialization concept. over the next four years, the concept will be rolled out to all packaging lines at sites across the world.

the upgrade of the pilot line entailed a changeover from manual end packaging to an automized solu-tion. this presented a challenge in terms of fitting a large robot into the limited space of an existing production hall. also, scanners and label printers had to be installed for each aggregation stage to facilitate the necessary data collection.

beTween THe Linesunique barcodes to prevent counterfeit

a vast number of people were involved in the project which entailed work ranging from building a new it-infrastructure and adapting the logistics chain and production processes through procurement of new equipment and change of packaging materials to release of new standard operating procedures.

nne pharmaplan provided support for factory and site acceptance tests (fat/sat) and was responsible for ensuring compliance with gmp requirements. moreover, we were in charge of coordinating and supervising commissioning and for complete qualification in all phases in connection with the implementation of the serialization system and pal-letizing robot.

nne pharmaplan’s pool of resources counts 350 highly skilled consultants and project managers within automation & it and packaging lines as well as 30 consultants focusing exclusively on serialization. all have hands-on experience from the pharma and biotech industries.

nne pharmaplan has provided consulting services in the serialization field to numerous customers, and implemented and validated more than 60 packaging lines worldwide to incorporate serialization technology. below we have highlighted three of our most recent projects.

our customer has initiated a Global serializa-tion programme (Gsp) to implement the equip-ment and systems required to comply with global codification and serialization require-ments.

the program sets out to define a common standard for serialization processes across the entire supply chain from production to warehouses including equipment, automation and it solutions. each step in the supply chain checks and reports which serial numbers have been received and shipped (from/to whom) in order to constantly track the individual product.

so far, major implications have included the replace-ment of packaging lines, changes in warehouse processes and implementation of new it solutions. all solutions are designed with high flexibility in mind in order to accommodate a diverse and continuously changing landscape of requirements.

nne pharmaplan is assisting in all aspects of the pro-gramme realization effort and is providing resources within the fields of automation and it, procurement and validation.

even though our customer is not one of the companies to be most affected by counterfeit, the company has taken important steps to pre-vent counterfeit issues going forward.

in close collaboration with nne pharmaplan and nnit, they are currently introducing a unique 2d barcoding system into their worldwide production plants. the barcode is printed on the packaging and contains information on where the product origi-nated as well as a unique identification number.

from the drawing board to productionthe company initiated their serialization efforts in 2009, when they asked nne pharmaplan and nnit to assist them in making the right choice of technol-

ogy and subsequently to develop a solution which would be eligible for global rollout throughout the organization.

the collaboration continued through the implemen-tation phases, where nne pharmaplan and nnit performed impact assessments of all global sites to identify the amount of work to be done to introduce the 2d barcoding system to each site.

the effort requires the production machinery and it systems to be converted in order to accommodate the 2d barcode system.

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Project references

BaselClarens-Sur-MontreuxSan Francisco

Irvine

Moscow

TianjinTEDA

Kuala Lumpur(Selangor)

Bangalore

Noida

New Delhi

Mumbai

Frankfurt(Bad Homburg)

StockholmUppsalaLund

Shanghai

Lyon

CopenhagenKalundborg

Hillerød

Hjørring

Guangzhou

Boston(Cambridge)

Research Triangle Park(Morrisville)

Philadelphia(Berwyn)

Cork(Kinsale)

ChartresMarburg

Skt. Petersborg

Offices

Curitiba

Brussels

TangerangJakarta

São Paulo

TrACK reCord – LoCAL proJeCTs for A GLobAL issue

nne pharmaplan is the world’s leading engineering and consulting company in the complex field of pharma and biotech. We cover all segments from biopharmaceuticals and vaccines to medical devices and help our customers develop, establish and improve their product manufacturing. nne pharmaplan employs 1,700 people at more than 30 locations around the world.

engineering for a healthier world – our role in an industry that improves people’s lives worldwide. to learn more about our company, please visit our website.

nordiC lars olsensubject matter expert+45 3075 7362 lao@nnepharmaplan.com

europe thomas billserialization business Consultant+45 3079 0489tobl@nnepharmaplan.com

nnit torben vogt subject matter expert +45 3075 4338tovo@nnit.com

usagilad langersubject matter expert+1 4154056743 gidl@nnepharmaplan.com

scan to visitnnepharmaplan.com

GLobAL dAnisH mAnufACTurer of insuLin

project: global solution - serialization + aggregationChinese solution - serialization + aggregation

GLobAL swiss pHArmA- CeuTiCAL mAnufACTurer

project: end of line serialization + aggregation solution

GLobAL AmeriCAn pHArmA- CeuTiCAL mAnufACTurer

project: serialization requirement and product analysisproduct tracking strategy

GLobAL mAnufACTurer of sKin TreATmenTs

project: serialization requirement and product analysisproduct tracking strategy

GLobAL dAnisH mAnufACTurer of AnTi- infeCTion TreATmenTs

project: serialization requirement and product analysisproduct tracking strategyscoping and planning of global serialization solution

version 2 - april 2013