Part of PTC's approach to achieving that goal is extending its Windchill PLM platform with new capabilities in the areas of quality management, including corrective and preventive action (CAPA), along with requirements traceability and more robust document management functionality.
For example, PTC's acquisition of MKS Inc. added the Integrity requirements management and verification platform to Windchill 10.1, while its 2009 buyout of Relex delivered a risk analysis platform that can help engineering organizations identify potential areas of compliance risk early in the design process so they can be mitigated then as opposed to later when it is more costly, Lloyd said.
Even as a relatively small company, Livengood, which manufactures a mobile patient care environment, is feeling the weight of an increasingly complex regulatory climate. As a result, the company has put a number of new processes in place and is leveraging tools like PTC's Creo Direct to inject more rigor into its document control processes and to aid in the creation of DMRs and DHFs. "Being a startup and a small operation, we put in place controls that would get us the results we needed for the first edition (medical electrical equipment compliance standards)," Joe Livengood, the company's chief technical officer, told us.
Subsequent editions of the standard are upping the ante, requiring Livengood to consider making additional changes to its processes, potentially adding PLM over time as they scale to new markets and as the varying configurations of the product get more complex.
For Carestream Health Inc., a maker of medical, dental, and molecular imaging systems, PLM, and specifically Aras PLM, is an essential ingredient in its ability to establish and enforce well-documented, quality systems and manufacturing practices that are critical for meeting compliance. Yet that wasn't always the case.
Traditionally, the company met its compliance requirements using a variety of stovepipe systems and with manual processes. However, the ever-changing complexity of the regulations, coupled with its global operations base, made it increasingly inefficient for Carestream to continue doing compliance in this fashion, according to Dave Sherburne, the company's director of R&D effectiveness and engineering IT. He told us:
We'd control errors by throwing people at the problem. It wasn't that we were in danger of non-compliance, it was that we weren't getting as much innovation out of people. That kind of waste is invisible, it's dangerous, and it's frustrating to people, but that's what happens when you don't have good systems.