PTC Inc. (Needham, MA) describes the recently introduced 10.2 version of its PTC Windchill PLM (product lifecycle management) software as adding capabilities that help manufacturers improve productivity and streamline compliance with new government regulations, including the FDA’s Unique Device Identification (UDI) requirement to take effect in 2014. Additionally, PTC Windchill 10.2 offers expanded compliance with Conflict Minerals legislation as well as productivity enhancements for both users and admins.
The PTC Unique Device Identification (UDI) solution in PTC Windchill 10.2 is said to accurately track all submissions to the FDA as well as communications from them. Image courtesy of PTC and Business Wire.
PTC reports that its newly developed, preconfigured PTC UDI solution can help medical device manufacturers comply with the FDA UDI requirement, which obliges UDI labeling of product numbering, product version information, and product configuration data. Its solution, according to the company, includes the ability to collect and manage UDI data from multiple data stores. It automates the submission process with out-of-the-box review and approval workflows, and its pre-submission data validation algorithms are said to be identical to those used by the FDA. The UDI solution, adds the company, can streamline UDI data management, both to accommodate product versions/variants and to meet the needs of future regulatory requirements from the FDA and other global agencies.
Version 10.2 also expands compliance with existing Conflict Minerals legislation, as the first SEC filing deadline of May 31, 2014, approaches. Windchill now manages part-level Conflict Mineral compliance status declarations in addition to existing supplier level Conflict Mineral compliance declarations. This, says PTC, provides a comprehensive conflict minerals management system to determine the presence of conflict minerals in products, perform reasonable country or origin inquiries and due diligence, report on conflict mineral compliance status, and integrate with critical product development processes.
PTC Windchill 10.2 allows manufacturing engineers to visually construct process plans. Image courtesy of PTC.
PTC Windchill 10.2 also includes new quality-related capabilities that help accelerate problem resolution, the company says. These capabilities include tighter integration between quality analyses tools and core change management processes, which can help improve product quality sooner.
PTC Windchill 10.2 now also provides out-of-the-box templates for new CAD documents in Autodesk Inventor, AutoCAD, and SolidWorks. PTC Windchill document management capabilities have been expanded within the familiar Microsoft Windows and Microsoft office environments, and users can upload any CAD content in any state to the server workspace.
PTC Windchill 10.2 users can visually interrogate data relationships, including requirements that are managed in PTC Integrity application lifecycle management software. Image courtesy of PTC.
New system administration capabilities include simplified and automated PTC Windchill support within a cluster environment, which is said to help reduce the total cost-of-ownership (TCO) as well as the risk of system downtime. Version 10.2, says the company, also reduces the time and administrative overhead associated with creating new test and development instances by providing repeatable, automated, re-hosting capabilities that are configurable to a specific customer configuration.
Other enhancements available in version 10.2 include relationship navigation capabilities that extend to objects and requirements created using PTC Integrity application lifecycle management software. The same configuration rules are enforced across both PLM and ERP (enterprise resource planning) systems. Users can also visually construct manufacturing process plans from the engineering BOM (bill of materials). PTC Windchill 10.2 adds integration support for the Cadence Allegro Design Workbench (ADW) team design option authoring application.
For more information on PTC Windchill version 10.2, visit PTC.
Sources: Press materials received from the company and additional information gleaned from the company’s website.