Some regulations are specific to particular industries. Some are specific to individual countries. Some are common to U.S. companies whether they operate solely domestically or internationally. Based on their industry, companies are required to prove compliance with different regulations at different stages in a product’s lifecycle. For instance, manufacturers may have to comply with extended producer responsibility (EPR) legislation and its environmental protection subsets including restriction on the use of certain Hazardous Substances (RoHS), Waste of Electric, Electronic Equipment (WEEE) and End of Life Vehicles (ELV). Process Visibility and Integrity is a critical medical compliance requirement, and aerospace and defense industry businesses are pressed by International Traffic in Arms Regulations (ITAR) weapons security requirements.

As different as individual regulations may be, they all share a common need to:

• manage information access, retrieval and retention;
• maintain process visibility and integrity;
• create enterprise awareness and ownership of both the regulations and the process of complying with them.

In each case, many people need access to the documents and records that provide evidence of compliance so they can work together to support it. In product companies, this includes design engineers, manufacturing engineers, sourcing, procurement and logistics personnel, quality, environmental health and safety and information systems teams, to name just a few. In fact, when employees are involved in this way, aware of the scope of their company’s regulatory compliance effort and take ownership, they take greater responsibility for their role in the process, contributing to higher success.

Companies can strengthen their compliance initiatives and accomplish the mandates above by including PLM as part of their overall compliance strategy and framework. Enterprise PLM provides a secure foundation that enables companies to directly enforce and validate regulatory compliance. It facilitates processes that help manage requirements such as document and record management, configuration management, change management, workflow, subscription and notification services, security and access control, system audit management and reporting.

There is no doubt that PLM helps companies avoid failure to comply with regulations – which can result in serious consequences including recalls, seizures, hefty fines and even jail time. But beyond that, it also helps improve productivity and limit downstream costs in many ways, including capturing knowledge and re-using industry best practices. Across virtually all industry groups, product designs can now be electronically documented and virtually validated against global regulatory and competitive functional requirements by embedding both enterprise-specific and industry-specific knowledge into software-based “best practices” templates to ensure compliance throughout new product development and manufacturing processes. Organizations that capture and re-use that knowledge gain a proven competitive advantage even as they minimize the risk of regulatory non-compliance.

The more companies integrate lifecycle steps into the compliance process, the easier and less costly it is to manage. The key is a PLM system that has the flexibility to handle requirements for each industry, each set of products and each set of regulations. It also needs to be able to adapt to changing business environments and regulations and to provide a scalable architecture that leverages and protects existing IT and regulatory compliance investments. These attributes are core to technology solutions from UGS PLM Software.

So rather than fearing compliance as an expensive and daunting challenge, companies incorporating PLM can turn compliance initiatives to their advantage. According to AberdeenGroup, "Organizations should be viewing this (regulatory compliance) not as a requirement, but as an opportunity to improve business processes by implementing core content management capabilities that will provide efficiencies in the business processes while enabling their organization to meet the new regulations."ⁱⁱ Indeed, many organizations are using compliance as a business-improvement and innovation driver. PLM provides the information management tools that can automate compliance activities, establish global innovation networks that foster collaborative process improvements across the extended enterprise and free a company to focus on the improved innovation that will drive its competitive leadership and profitability in the future.

To learn more about how UGS PLM Software solutions provide an ideal framework for compliance initiatives, please visit http://www.ugs.com/initiatives/regCompliance/ where you will find whitepapers, webcasts, success stories, recommended reading and more. Also in this month’s newsletter don't miss two great articles on environmental compliance: The ABC’s of Environmental Care in High Tech and Go Green! Kick-Off the Fall Season with Teamcenter’s Greater Powers for Environmental Compliance. While compliance requirements will continue to grow you have the tools available to you now to reduce your risk, reduce your costs and build a more competitive business in the process.

ⁱ AMR Research, “Spending in an Age of Compliance,” by John Hagerty and Fenella Scott, 2005.

ⁱⁱ AberdeenGroup, “The design for compliance benchmark report," 2004)