Regulatory Compliance Across the Product Lifecycle

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Regulatory Compliance Across the Product Lifecycle: Reduced Risk and Lowered Costs Through Proactive EH&S examines the importance that regulatory compliance and product related EH&S play in protecting the value available from PLM across the product lifecycle. Please enjoy the free Executive Summary below, or click the report title above to download the full PDF (free of charge, no registration required).

Table of Contents

  • Executive Overview
  • Compliance Is Critical to Sustained Product Value
  • Non-Compliance Surfaces at Inopportune Times
  • Moment of Regulatory Crisis– Found in Design
  • Moment of Regulatory Crisis– Found in Production
  • Moment of Regulatory Crisis– Found in Logistics
  • Moment of Regulatory Crisis– Found at Customer
  • Implementing Design for Compliance
  • Implementing Proactive Compliance Monitoring
  • Documenting Compliance
  • Recommendations
  • About the Author

Executive Overview

The value that Product Lifecycle Management (PLM) initiatives provide to manufacturers comes in many forms, including: faster introduction of products, reduced product cost, increased product sales, higher product quality, reduced waste and more valuable product portfolios. These are some of the more positive aspects of PLM that people like to talk about. One area that doesn’t get as much attention is compliance.

Regulatory compliance, while nobody would dispute the critical need for it, is not as exciting or enjoyable to discuss. The problem with leaving compliance unspoken is that a significant amount of the value associated with Product Lifecycle Management is dependent on addressing compliance in a cost-effective manner. In fact, all of the benefits of PLM could be quickly erased by significant non-compliance events that impact the company through fines, penalties, negative publicity or prohibition to sell a new product in key markets. Compliance risk may not be a glamorous topic, but it is critical to the development and sale of profitable products and responsible, sustainable corporate profitability.

Few would disagree with placing compliance to regulations as a goal for a PLM initiative, but at what level of priority? At what cost? For which jurisdictions? Without proactive management, regulatory problems are often found at the most inopportune times. This paper will review real examples of “moments of regulatory crisis”, their impact on the business, and the value that focusing on compliance throughout the life of the product can provide. Design for compliance and proactive monitoring can help companies navigate the myriad of regulatory requirements required for profitable business.