While the European Union's Restriction of Hazardous Substances directive has garnered the lion's share of compliance headlines this year, regulatory compliance is second nature in many manufacturing industries. Food manufacturers, pharmaceutical companies and medical device makers long have operated under the watchful eye of the U.S. Food and Drug Administration, for example. The aerospace industry must meet Federal Aviation Administration requirements. And there are many others.
The complexities of compliance can be enormous. For medical device manufacturers, for example, one of the biggest challenges "is complying with a multitude of regulations involving validation of the quality and efficacy of their products, but also their manufacturing and service processes," says Jim Brown, vice president, global innovation and engineering research for analyst firm Aberdeen Group.
And technology is playing "an increasingly significant role" in helping firms integrate compliance requirements into existing business processes, according to AMR Research. The consulting firm predicts that some $27.3 billion will be spent on compliance initiatives in 2006, with nearly $9 billion of that earmarked for technology.
Product lifecycle management (PLM) solutions are helping meet the need. "PLM vendors are recognizing the need to help their customers deal with the tangle of regulations -- whether internal, customer-specified, or external -- that impact their product development cycles," says Aberdeen's Brown.
ArthroCare Corp. is familiar with the tangle of regulations, and the aid appropriate technology can provide. The Austin, Texas-based manufacturer of minimally invasive surgical products recently was honored for the second consecutive year as one of the 100 fastest-growing publicly traded technology companies. Such growth presents challenges, however. As a manufacturer of medical devices, ArthroCare operates in a highly regulated industry and must meet stringent quality-system requirements of the U.S. Food and Drug Administration. Those requirements include a documented corrective-action system, which ArthoCare initially met via a paper-based system. That meant printing out forms, routing them to the appropriate personnel, and manually tracking their progress.
"That system works fine for a certain number of employees and a certain number of locations," explains John Pustell, ArthroCare director of operations. It grew less optimal, however, as the $214 million company expanded to include locations in California, Texas, several European sites and a manufacturing plant in Costa Rica. Ultimately, "walking the paper around didn't work anymore," he says -- particularly given the importance of enforcing timelines, which can be a sticking point with quality audits.
ArthroCare turned for relief to a PLM solution from Agile Software Corp., San Jose, Calif. The company implemented Agile's PLM solution in July 2003, to help streamline its product development process, adding a product quality management module about nine months later. The quality module allows users to aggregate and track product and process problems, and includes workflows to automate the corrective action process. ArthroCare uses another workflow within the module for non-conforming material reports.
The implementation has eased record-keeping and improved document control, as well as improving information accessibility, Pustell says. Data is available in real time across all of the company's sites, and the ability to obtain electronic signatures is a benefit that is particularly important when operating across multiple sites, he notes.
And as for the individual responsible for maintaining the corrective action reports? "She is very excited to have more tools at her disposal," Pustell says.
