Editor’s Pick: PTC Expands Windchill Regulatory Compliance Capabilities

I’ve been a fan of PLM—product lifecycle management—since it was a notion that PDM (product data management) developers came up with to describe their future roadmap. PTC was one of the earliest proponents of PLM, and it was one of only a handful that really grasped and respected the enormity of the assignment they gave themselves. Those two characteristics—grasped and respected—are key to the reason that PTC Windchill has emerged as a leading PLM solution.

Solution is such an overused word that it’s almost lost its meaning in this context. PTC Windchill is really more of a mission-critical infrastructure for executives, managers, and, most of all, the hands-on engineers who need to manage the complex challenges and enormous data loads inherent in creating and servicing products so that their enterprise can compete better. All of the processes—say, engineering, manufacturing, quality, and service—and data such as analytics and legacy IP—can be managed, controlled, and communicated with PTC Windchill.

PTC recently announced the availability of version 10.2 of its PTC Windchill PLM solution, and this version reflects the company’s long history developing PLM capabilities that address the engineering and business complexities facing engineering firms as well as PTC Windchill users and system administrators. In particular, PTC Windchill version 10.2 has expanded regulatory compliance capabilities.

For medical device manufacturers, version 10.2 offers a newly developed, preconfigured PTC Unique Device Identification (UDI) solution. The intent here is to provide medical device manufacturers with preconfigured productivity tools that comply with the FDA’s new UDI requirements for product numbering, product version information, and product configuration data that take effect next year. PTC UDI’s capabilities include out-of-the-box review and approval workflows that automate submission processes. Its pre-submission data validation algorithms are said to be identical to those used by the FDA, and the solution can collect and manage UDI data from multiple data stores as well as accommodate product versions and variants.

For a bunch of industries, PTC Windchill 10.2 now manages part-level Conflict Mineral compliance status declarations as well as existing supplier level Conflict Mineral compliance declarations. This means that PTC Windchill’s conflict minerals management system can now determine the presence of conflict minerals in products, perform so-called reasonable country of origin inquiries and due diligence, report on conflict mineral compliance status, and integrate with critical product development processes.

These are all good things. Still, ultimately the success of a system like PTC Windchill comes down to one thing: User acceptance.

To that end, version 10.2 provides end users with out-of-the-box templates for new CAD documents in Autodesk Inventor, AutoCAD, and SolidWorks. Its document management capabilities have been expanded within the Microsoft Windows and Microsoft Office environments, and users can upload any CAD content in any condition to the server workspace. Users can also visually interrogate data relationships and visually construct process plans. New system administration capabilities include simplified and automated PTC Windchill support within a cluster environment and reduced time and administrative overhead when creating new test and development instances.

There’s a whole lot more going on in PTC Windchill version 10.2. You can read about many of the new features in today’s Pick of the Week write-up, but your best options are found in the links at the end of the main write-up. Make sure to take in the intro video for a quick overview of what version 10.2 can mean for you. Anyone in medical device manufacturing should hit the link to learn more about the new preconfigured UDI capabilities in PTC Windchill 10.2. It is a prime example how PTC Windchill helps you create an infrastructure to manage your complex processes and competitive environment better.

Thanks, Pal. — Lockwood

Anthony J. Lockwood

Editor at Large, Desktop Engineering

Read today’s pick of the week write-up.

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