The document discusses the increasing challenges companies face in complying with global safety regulations, highlighting the risk of losing innovation, profitability, and brand image if non-compliance occurs. It emphasizes the need for strategic solutions, including establishing standard procedures, compliance visibility, and automation in product development to ensure adherence to regulatory norms. The author, Vedant Borse, stresses the importance of a proactive approach to managing product regulatory compliance to avoid long-term costs and operational inefficiencies.

1. What are you prepared to lose: Innovation, Profitability
or Brand Image @ Cost of Non-Compliance
Building Strategic and Effective Approach to Product Safety and Stewardship
January 18, 2014
| VEDANT BÖRSE | SAP PLM / PPM / SUSTAINABILITY ADVISOR | HCL AXON |
prcProduct Regulatory Compliance
White
Paper

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Proliferation of safety regulatory requirements and product
liability has increased challenges for companies who want
to and must comply with all laws, regulations and
standards in any country where they sell their products. It
is not easy task, just to identify the regulation that could
apply to the company’s product and then implement it.
Organizations have thus struggled to holistically design,
test, monitor and comply to meet the appropriate
worldwide standards. If not approached strategically, this
direction can come at a high cost; and in a margin-sensitive
industries, profitability still has a dominant position. The
key is to build a mature and strategic Solution to handle
Global Compliance.
Contents
Cost of Non-Compliance ..................3
Product Compliance Driver ..............4
Compliance Challenges ....................5
Compliance Automation Benefits ....7
Solution Approach............................8
Looking Forward...............................9
About Author..................................10

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Cost of Non-Compliance

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Product Compliance Driver
Key Driving Factors for Product Compliance

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Compliance Challenges
Challenges Encountered in Achieving Product Compliance

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Compliance Infrastructure
Use of Automation to Support Product Compliance

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Compliance Automation Benefits

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Solution Approach

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Looking Forward
Compliance to regulatory norms is a law that every company has to adhere. They are
in place and bound to exist. Companies that do not address compliance issues put their
Innovation, Profitability, Growth and Brand Image strategies at risk. The long-term
costs of being unprepared are simply too high. Companies should thus make every effort
to comply with regulatory requirements
Companies must proactively adopt organizational measures to increase the visibility to
compliance issues, adopt policies and processes that encourage compliance to be
embedded into the product at a basic level, and enable designers with technology to
assist in design decisions early in the lifecycle. And finally put together a compliance
infrastructure that supports long-term approach, which can be applied in a repeatable
and sustainable manner to new regulations and new products before an actual crisis
occurs. With right solution design by building automation at critical steps in product
development processes, companions can avoid spending time on manual processes of
monitoring product compliance. Automation framework can provide real-time
dashboard, enabling designers to focus more time and energy on building new
innovation. The key to success and avoiding revenue loss in this new, constantly
evolving regulatory environment is to take a scalable and proactive approach designed
to the unique needs and risks of your business.
Companies planning to manage production regulatory compliance should;
• Establish Standard Operating Procedures in Product development processes
• Build early warning system and compliance visibility report from product
development to end of life stage
• Continuously improve and update the processes
• Setup compliance infrastructure and software solution to ease adherence to
compliance
• Build closed loop procedure

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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 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