As manufacturers struggle under the weight of regulatory compliance, a growing number of IT experts and business strategists are making the case that Product Lifecycle Management (PLM) is a natural fit for helping to automate and manage the process as part of the early design phase.

With regulations varied across industries and countries (not to mention across states, in some cases), manufacturers -- particularly those that build and sell product on a global basis -- are faced with a logistical nightmare: to aggregate and track all the required data and produce reports that establish and track compliance. Manufacturers of cell phones or computers that sell product in Europe or China, for example, need to meet recycling targets as part of the European Union's new WEEE (Waste Electrical and Electronic Equipment) regulations. Eventually, they will need to comply with guidelines established by RoHS (Restriction of Hazardous Substances).

Car companies are facing similar concerns brought on by the End of Life Vehicle Directive (ELV). Medical device makers are looking at electronic signature requirements resulting from the Federal Drug Administration's CFR Part 11 compliance, and the list goes on.

Further complicating matters is the fact that some manufacturers could be required to comply with multiple regulations, each of which would vary depending upon the standards of a particular region. With most companies depending upon an extended supply chain to produce parts or assemblies used in their end product, keeping tabs on what is and isn't compliant can exceed a manufacturer's control if automation is not present.

"There are so many variations -- if it was only one country or the whole world had the same set of standards, companies could make one product that complies," says Eric Karofsky, senior research analyst for PLM at AMR Research Inc. (Boston). "But every country has different restrictions, which makes for a huge data-collection and data-management burden."

It's clear manufacturers are turning to technology as a solution to the problem. According to a recent report by AMR, U.S. companies plan to spend $15.5 billion on compliance this year alone, with the grand total to hit around $80 billion between now and 2009. The lion's share of that figure will go to technology purchases and people to use it. Nearly two-thirds of those surveyed said they plan to add or improve their current compliance-management systems.

What's not as apparent, however, is what kind of enterprise system is best suited to manage compliance. Some make the case that ERP or MES systems are the place to tackle compliance since they're closely tied into all of the manufacturing steps related to building a product. Others say proprietary compliance management systems are the best bet. Yet a growing constituency of experts and manufacturers argues that those systems address compliance too late in the process, putting companies at risk for substantial time-to-market delays and huge penalty costs if non-compliance is not found and resolved early in the design phase. (Check out the final installment of Managing Automation's three-part webcast series on managing regulatory compliance by clicking here.)

"Compliance isn't just something you test products for afterwards -- you actually have to design for compliance," says Eric Larkin, chief technology officer and co-founder of Arena Solutions Inc. (Menlo Park, CA). "Requirements have to be applied to a product early on in the design stage because otherwise, you may end up designing around components or subassemblies that can't be made compliant."

PLM is the answer to compliance management, Larkin and others contend, because it's already employed as the system to manage the product record. "A PLM system is fundamentally about managing the documentation and design around a product," he explains. "ERP may tell you what parts are in a product, but it doesn't tell you what the design of those parts is and whether the design meets compliance requirements. A product record is where you go to get that information."

And that's the key point: Using PLM to drive compliance management is no different than using the technology to manage any aspect of the engineering process, experts maintain. It's all about leveraging technology to support new and improved ways of doing business. Manufacturers must make sure the right design information is properly captured and expressed -- and that engineers inside and outside the organization follow the PLM system's design dogma to remain in compliance with proliferating global regulations.