Integrating Packaging, Labeling and Artwork Management with Supply Chain

1. Integrating Packaging, Labeling and Artwork Management with Supply Chain
May 23, 2012
| VEDANT BÖRSE | SAP PLM / PPM / SUSTAINABILITY ADVISOR | HCL AXON |
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plamPackaging Labeling & Artwork
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In the era of competitive business, every company strives to
reduce time to market, deliver quick product mix, and
quickly change products to market needs. Packaging,
Labeling and Artwork development processes are under
constant pressure to deliver an increasing number of
projects in an increasingly compressed time frame. Life
Sciences and CPG companies on the other hand are
governed by FDA validation, stringent quality norms and
GMP. Errors can be costly, damaging and even putting
company on stake due to recalls or FDA warning, fines.
Packaging specification, package engineering and
development team lacks coordination, resulting in longer
Packaging design to Final Product development cycle, thus
inhibiting the organization to quickly bring products to the
market, eventually impacting its growth. Package copy,
labeling and Artwork, on the other hand, play an important
compliance role in communicating usage instructions,
ingredients, drug facts, safety and efficacy data and
patient information. A small mistake in the labeling copy or
registration process, and the products could be subjected to
FDA fines or even recalled.
Contents
Business Drivers.............................3
Industry Challenges....................4
Automation Nightmare .............6
Solution Approach......................8
Integrated Packaging &
Labeling.......................................11
Looking Forward........................13
About Author..................................14

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Business Drivers
The key Business drivers that govern the whole Packaging and Artwork Management Process are;
However in order to meet these demands,
organization needs to examine the complete
product development chain, the processes and
the technology it relies on. Unfortunately even
the most matured organization with best
practices relies on applications which are
narrowly-focused expert tools or homegrown
applications, which delivers some localized
benefits. Furthermore these applications are no
longer supported by software vendors or prone to
frequent breakdown leading the company
towards security venerability. To make the
situation worse these application works in silos
and do not communicate with different processes
resulting in Redundant and Repeat process.
And companies whose entire business revolves around packaging and labeling needs to ensure that
they don’t make any error. One error can damage company’s image due to recalls or FDA warning,
fines and also result in loss of revenue. Organization should thus look for collaboration across various
business units and build visibility across entire process chain so that they can reduce time to market
and also reduce the compliance risk.
• FDA compliance
• Time to Market
• Collaboration across operating units
• Visibility across process chain

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Industry Challenges
Packaging, Labeling and Artwork Creation Process is under continuous pressure due to growing
number of products, Sales Promotion or re-launch of existing products, shorter time to market,
changing compliance requirement, and integration with multiple units.Thus the challenges with these
packaging processes are abundant.
Packaging, Labeling and Artwork
management involves collaboration
with various internal and external
units.This includes
o Product Development
o Package Engineering and
Configuration
o Regulatory Affairs and
Labeling Management
o Artwork Management and
Vendor Collaboration
o Change Control
o Packaging Product
Manufacturing
Interacting with so many departments and external agencies possess its own challenges.
Disintegrated Formulation, Specs, Packaging, Labeling, Artwork, SKU and also Sales, Accounting &
Operations results in;
o Long Packaging BOM to SKU cycle
o Redundant and Repeat process
o Lack of visibility across the chain
o Lack of coordination leads to inventory obsolescence
o Lack of consistent metrics / analytical / error reporting
o Errors, FDA warning, recalls

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Packaging and Artwork development process on one hand is under pressure to deliver quick changes
to product shape, design, labels and artwork in an very shorter time frame, on the other hand, Life
Science and CPG Industries are governed by FDA validation, stringent quality norms and Regulatory
compliance. Regulatory guideline by agencies like FDA, MHRA, etc. demand compliance within
packaging, labeling and artwork processes to safeguard product consumer safety. Keeping up with
these changing compliance requirements in different countries is a challenge. The upcoming (2014
and nutrition labeling in 2016) Regulation (EU) no. 1169/2011 on the provision of food information to
consumers, is focused primarily on labeling. Some of the key regulation includes;
o U.S. FDA 21 CFR Part 11: Electronic Records Electronic Signatures
o Clause 11.10(e): Maintains electronic records (an audit trail) for revision and change control
o EU Directive 91/356 (EU GMP Guideline): Document management and storage
o Health and Safety Regulations
Apart from lacking coordination between different business units and issues due to Regulatory
compliance, some of the other challenges that are encountered in Packaging, Labeling and
Artwork include;
o Lack of integrated Package & Product Renovation process
o Redundant specs/ recipes/ Labels/ Artworks/ Packaging Configuration
o Weak version control and change Management
o Validation challenges of BOM for effective Label Specification
o Validation challenges against the right Artwork version
o No central repository of Regulatory Specifications, Artworks, Sketches, master
boards, etc.
o No integration to other PLM related systems
o No tool to govern & facilitate detailed PLM tasks and handoffs
o Difficulty in Sourcing Compliant product
o Validate against the inventory

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Automation Nightmare
In order to address the Challenges, companies build a
solution, which on paper is the best designed
solution. IT Landscape of Major LS and CPG
companies is build around the philosophy that R&D,
Packaging, Artwork processes are unique processes
and needs niche software that works dedicated for
these processes. It has all the spices that perfectly
meet all the specification demanded by the business.
However, the reality is that it’s a nightmare for
business folks to use, and a big headache for IT to
manage and maintain it. It is either a home grown
solution tailored to fit, which could be a legacy
application living its last breath and could break any
day, and put the business at stakes or it could be a
amalgamation of some the best of bread solution
interwoven is such a way that only few of the Techies
in IT team knows how to maintain them. Enguinity,
Schawk’s BLUE, Maximo, Trackwise, Oracle, SAP,
Sharepoint, Hyperion, Mircosoft office, you name it
and they are patched up to build a best of breed
solution bouquet. With so many software in place
comes with its own sets of problem. Some are
integrated, some are broken and some needs manual
copy paste of data, resulting in risk of making some
serious mistakes. And once these pieces start falling
apart, companies spend millions of dollars asking
consulting companies to evaluate what tools are
good for them, when they already have SAP or Oracle
ERP at their home capable of handling it. What’s
rather required is a little bit of innovative thinking on
top of it.
Many Companies take pride of building these complex webs of software. And companies which are heavily
dependent on Packaging process for their products or niche private label companies has a common reason to
these meshes of software. “We are unique…”, “We are different…”. “Our processes are proprietary; it cannot be
used by any other company”. And finally, even after having so many software, they build a large pool of so-
called master data team, whose primary job is to just copy data from one system to another. Being a consultant

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to these companies and an outsider, I have seen that 80-90% of the processes of these companies are same.
Some has their own best practices and some don’t, or do it a little differently.
Some of key Issues and Challenges these companies’ faces due to multiple software are;
So what does executive wish….
Executives wish to have a highly complaint system with
flexibility to adopt quick changes and speed up the process.
They want a globally unified regulatory process which also
meets region regulatory compliance, like FDA or MHRA
guidelines. They want a globally scalable solution while
ensuring that the systems are complaint to local needs.
They want to reduce time to market but at the same time
want to build flexible packaging derivatives. And finally
want a single unified process, providing visibility to entire
chain and at the same time want an ERP centric packaging
and labeling solution.
o Host of Legacy application with
Disintegrated Formulation, Specs,
Packaging, Labeling, Artwork, SKU and
change control process and also Sales,
Accounting & Operations to support
management
o Disintegrate Supply Chain to Product
development and Packaging Systems
o No single tool to administer & facilitate
detailed tasks and handoffs
o No consolidated reporting capabilities
o Non-integrated/inconsistent, manual
post launch tracking & analysis

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Solution Approach
So how do we do it? First of all, we need to understand
that Technology is not the answer for all problems; nor is the
Process Improvement, the solution to a problem. Rather
process improvement complimented by technology is the
right answer.
The first process starts with building a streamlined process
flow with appropriate stage-gates and a seamless hand-off
between each process steps. Majority of the issues in
Packaging and Artwork processes are due to lack of proper standard operating procedure and process
guidelines.
Companies should build Configurable Packaging that brings flexibility to build many derivatives of the
packages. Many companies create one unique packaging BOM for each individual product. Situation turns
worse, when individual Packaging BOMs are created for Promotion Packs and Displays configurations.
Rather a combination sets of Primary, Secondary and Tertiary packaging can enables a company to build any
many products as possible for different formulas, region, regulation, brands, and companies. Building Scalable
and flexible processes that can be deployed globally should be the mantra.

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Artwork processes on the other hand are still
managed by manual process. An artist receives
instructions in email, creates drawings in Mac
computers and then finally stores them locally. Entire
drawing design process becomes artist dependent
rather than process dependent. Increased
outsourcing of Artwork to subcontractors adds to
further compliance risk and issues due to mistakes in
Artwork communication. In the entire process, it has
further been observed that overall review and
approval process time is increased significantly.
However at a closer look, we realize that Artwork
Management is nothing but a combination of good
Project Management, Repository Management,
Version and Label regulatory control and actual
Artwork authoring process. Except authoring
Artwork, all other processes can be managed in ERP
software like SAP or Oracle. These softwares are
capable of Artwork Task management, maintaining
Central Artwork repository, accessible over web
anywhere, Version control, Access control, extensive
Search option across all artwork data and content
inside artwork, Audit Log and workflow.
Similar innovative approaches can be adopted to
manage product at its inception stage at recipe
management to Label Specification, Regulations to
all the way to supply chain. During my years of
journey in consulting industry, I was able to define an
integrated Process, which could enable the
organization to create multiple product derivative
with minimal BOMs, Manage Artwork Management,
enable the Regulatory labeling specification
guidelines linked to Artwork and manage the entire
lifecycle of Packaging configuration request to
Artwork to final SKU development built.
Visibility is essential for sales to know which packing
is saleable, for engineering & product team to see at
what stage are the packaging NPD or Change
requests. So a good reporting view should be built for
visibility across process chain

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Packaging, Labeling and Artwork process should be further complimented by automation software to speed up
the development process. While selecting the software, companies should look for few integrated softwares
that meets the business required, rather that pick all best of breed software. Explore the potential of existing
ERP system within the organization. SAP or Oracle ERP have many modules with hidden potential for
Packaging configuration, Labeling and Artwork Management. Effective use of software would reduce IT
nightmares and allow Product Managers to spend more time in building better product and spend less time
coordinate task between each departments.
Some of the Key Ideas include;
o Build integrated Process
o Mature Change control and workflow approval process
o Intelligent lifecycle report
o Automation to pull compliant data for final assembly
o Portfolio based project execution for NPI project initiation and Regulation change

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Integrated Packaging & Labeling
Over years, I have worked with various Life Science and Consumer Products companies to build an Integrated
Packaging and Labeling framework that would enable organization to integrate their R&D recipes to
Manufacturing Supply Chain. iGPL (Integrated Global Packaging and Labeling) is an end-to-end SAP-based
solution framework that improves the Packaging, Labeling and Artwork management processes and reduces
the time to market by improving operations efficiencies from packaging initiation through manufacturing. This
solution framework manages packaging development and change management, enables adherence to the
stringent FDA norms, manage increasingly complex packaging development procedure in the Life Sciences and
CPG sector. Through the implementation of iGPL, organizations can realize greater and more rapid returns on
their investment during the Packaging, Labeling and Artwork design, development, and change phase. The
application framwork, designed for SAP PLM, includes capabilities for
o Packaging Initiation
o Packaging Specification
o Package Engineering and Configuration
o Regulatory Affairs and Labeling Management
o Artwork Management andVendor Collaboration
o Packaging Product Manufacturing
Integrated Global Packaging and Labeling Solution has been designed considering global regulatory norms,
Industry best practices, GMP and Business processes derived from various shop floors. The framework

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integrates various aspects of packaging including Specs Management, Packaging Configuration, RA controlled
Labeling Specifications, Artwork Task and workflow Management, SKU and Change control process. iGPL is
suitable for organization managing packaging solution in different legacy applicable and is planning to build an
integrated process around SAP from Recipe Development to packaging initiation to the final shop floor
manufacturing process for the packaged product. This framework has enabled organization to achieve the
following benefits;
Time to Market
Visibility
Automation
Sustainable Design
Regulatory
Change Management
Integrate the whole supply chain from Packaging initiation to SKU
End-to-end Lifecycle reporting
Integrated semi-automated solution
Foundational System for Future Enhancements (such as Quality Inspections
and Gated Development with Portfolios for NPDI)
CFR 21 complaint framework integrating Artwork to label Specs and packaging
configuration
Stringent but Quick Change process for Product conversions

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Looking Forward
Packaging, Labeling and Artwork Process is
critical for Product development. An eye-catching
and distinctive packaging gets consumer attention
and increases sale. Therefore the importance of
packaging process cannot be underestimated. At
the same time the process needs to be robust
enough to meet all product compliance and reduce
time to market.
Companions should thus build an integrated Process
chain with a continuously improved closed loop
process system. Build a stage gate process for entire
product development processes with unique phases
and checklist for Packaging, Labeling and Artwork
steps. Break the paradigm and culture of
departments working in silos.
While Government regulations are continuously
becoming increasingly stringent, with the advent of
social media, any mistakes in artwork are increasing
being published by social media user, thus sending
invitations to FDA, MHRA to increasingly knock the
doors of companies for their violation. Companies
should thus increase product safety and traceability
on a continuous basis.
Artwork and Labeling processes are not rocket
science that needs unique software. They are
processes that were somewhat neglected by ERP
software vendors but still have capabilities in its
existing PLM module, though they may not be
specifically called as Artwork Module or Packaging
Modules.
Avoid building a mountain of so called best of breed
softwares. PLM and ERP vendors have started
increasing their focus on Packaging, Labeling and
Artwork processes and have initiated building
dedicated software modules integrated within the
ERP suites. So look for current offering and future
roadmap of ERP vendors like SAP and Oracle in the
area of Packaging, Labeling and Artwork.
And finally, remove the misconception that your
labeling and artwork process is unique. There are
many companies managing their packaging,
Labeling and Artwork processes with the ERP based
PLM solutions in a very flexible and innovative way.
Companies planning to build a robust Packaging, Labeling and Artwork Process should;
o Build an Integrated and closed loop procedure for Packaging, Labeling and Artwork while
continuously improving and updating the processes
o Establish Standard Operating Procedures and governance process in Product development
processes
o Setup appropriate Packaging infrastructure and software solution to ease adherence to
compliance
o Build knowledgebase repository of Artwork to avoid rework and repetitive mistakes.
o Build early warning system and regulatory compliance visibility report from product
development to end of life stage
o Integrate Packaging, Labeling and Artwork process with R&D and Supply Chain

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About Author
Vedant Borse is an International PLM Professional with 18 years of Industry experience
working with Big 5, SEI CMM L5 firms in various Leadership capacities as Engagement
Manager, Enterprise Solution Architect and Functional Consultant. Mr. Borse has
delivered product development strategies (organization, global footprint, cost
management, processes, metrics), best practice methodologies, enabling technology
solutions, and change management programs to help improve company's product
development operation. He has developed PLM Roadmap for organization and helped
organizations in defining Enterprise Architecture for Life Science, FMCG, Oil & Gas, Hi-
tech, Automotive and E&C companies. His work involves understanding and selling
solutions (ROI) for high level business problems, incorporating all PLM and SCM
solutions. Mr. Borse is a Business process design and Modeling, Benefits realization and
Value engineering expert. He is a professional expert in various SAP PLM modules
including PLM 7.0, PPM 6.0 (RPM, cProjects, cfolder), PS, DMS, ECM, CAD Interface,
Recipe Development, Specifications Management, EHSM 3.0, SPRC 2.0 and
BusinessObjects PCM 10.0. His SAP experience includes 14 End-to-End SAP
Implementations (with Solution Manager) and 2 ECC 6.0 Upgrade, working as Project
Manager and Functional Consultant on various modules. Deep experience in
management of projects, solution choices, lead of team, quality processes, deployment
in heterogeneous environment, ability to develop strong customer relationships in
industry, author documents for projects, studies or proposals. To his credit, he has
developed an Integrated Global Packaging and Labeling Solution (iGPL), enabling
organization to condense time to market cycle and integrate the entire Packaging to SKU
cycle. He has also authored papers on Future Product Costing and Product Regulatory
Compliance. Mr. Borse has been a regular speaker in SAP Conference and had also
been faculty for SAP PLM Training to train SAP customer and SAP employees at SAP
Labs on SAP PLM and PPM.
Raleigh, North Carolina, USA
www.linkedin.com/in/vedantborse
www.slideshare.net/vedantborse
vedantborse@yahoo.com
The information contained in this White Paper has been obtained from various sources that I believe to be reliable. The document reflects my judgment at
the time and is subject to change without notice. The trademarks and registered trademarks of the corporations mentioned in this publication are the
property of their respective holders.
Copyright 2014, Vedant Borse