Understanding Regulatory Compliance


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There has been a rapid boost in the new global product-related regulations/standards development activities. As a consequence, organizations are trapped in the complex loop of various local, national and worldwide product targeted regulations.

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Understanding Regulatory Compliance

  1. 1. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL1 Understanding Regulatory Compliance
  2. 2. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL2 Understanding Regulatory Compliance There has been a rapid boost in the new global product-related regulations/standards development activities. As a consequence, organizations are trapped in the complex loop of various local, national and worldwide product targeted regulations. A simple reporting error, lack of proper registration and compliance can result in significant fines and penalties, ban on selling products/product recall, customer and supplier loss and severe damage to the corporate image.
  3. 3. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL3 Current Scenario  Governments, suppliers and consumers are emphasizing the determination of chronic health and environmental hazards associated with the life cycle of materials and products  Many manufacturers willingly take back or buy back their products from end users at the end of product life cycle for proper recycling and waste management.  Many product based companies are currently focusing on the production of safer and biodegradable materials. EPR “Extended Producer Responsibility” as an environmental policy approach in which a producer’s responsibility for a product is extended to the post-consumer stage of a product’s life cycle”
  4. 4. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL4 Regulations & Standards Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) Restriction of Hazardous Substances (RoHS) Waste Electrical and Electronic Equipment (WEEE) directive Toxic Substances Control Act (TSCA) The important characteristic of these regulations is that they transfer the risk management responsibility over to the producers and importers of the products
  5. 5. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL5 Challenges in Product Compliance Inability in obtaining correct and timely data from various sources Lack of knowledge among suppliers regarding regulatory requirements Gaps in recognizing and evaluating risks associated with non-compliance Lack of reliable, transparent and auditable business processes Lack of resources to facilitate process compliance assurance Inefficient & inappropriate data collection and reporting methods
  6. 6. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL6 Crucial Steps Identify and map the processes to specific regulation in a compliance matrix Understand the relevant product- targeted regulations Conduct a methodical gap analysis Ensure risk assessment of all products Develop an efficient data management system Supply chain collaboration is important Implement non- biological procedures Confirm safe and compliant handling, storage and transport Adopt “green chemistry” and make products “sustainable”
  7. 7. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL7 The Ultimate Apprise Implement automated systems that can help in managing regulatory compliance by analyzing regulatory changes, material data, suppliers, or BOM change, and quantity and movement tracking The best advice is “be prepared” and “comply fully as soon as possible” because non- compliance may have severe effects on your business and corporate image
  8. 8. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL8 For more details please visit the link below: http://www.wipro.com/Documents/understanding_regulator y_compliance.pdf
  9. 9. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL9 Wipro set up the Council for Industry Research, comprised of domain and technology experts from the organization, to address the needs of customers. It specifically surveys innovative strategies that will help customers gain competitive advantage in the market. The Council, in collaboration with leading academic institutions and industry bodies, studies market trends to help equip organizations with insights to facilitate their IT and business strategies. For more information on the Research Council visit www.wipro.com/insights or mail wipro.insights@wipro.com About Wipro Council for Industry Research
  10. 10. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL10 About Wipro Technologies Wipro Technologies, the global IT business of Wipro Limited (NYSE:WIT) is a leading Information Technology, Consulting and Outsourcing company, that delivers solutions to enable its clients do business better. Wipro Technologies delivers winning business outcomes through its deep industry experience and a 360 degree view of “Business through Technology” – helping clients create successful and adaptive businesses. A company recognised globally for its comprehensive portfolio of services, a practitioner’s approach to delivering innovation and an organization wide commitment to sustainability, Wipro Technologies has over 140,000 employees and clients across 57 countries. For more information, please visit www.wipro.com
  11. 11. © 2013 WIPRO LTD | WWW.WIPRO.COM | CONFIDENTIAL11 Thank You ©Wipro Limited, 2013. All rights reserved. For more information visit www.wipro.com No part of this document may be reproduced in whole or in part without the written permission of the authors. Wipro is not liable for any business outcome based on the views presented in this document. For specific implementation clients should take advise from their client engagement manager.