PTC Expands WindChill Regulatory Compliance Capabilities

PTC announced the availability of PTC Windchill 10.2, which the company says adds capabilities to help manufacturers improve productivity and streamline compliance with new government regulations.

PTC has developed a new preconfigured PTC UDI solution to help medical device manufacturers comply with the FDA Unique Device Identification (UDI) requirement in 2014, which will require UDI labeling of product numbering, product version information, and product configuration data.

The solution includes the ability to collect and manage UDI data from multiple data stores; automation of the submission process with out-of-the-box review and approval workflows, and pre-submission data validation algorithms identical to those used by the FDA; and streamline the management of UDI data, both to accommodate product versions/variants and to meet the needs of future regulatory requirements from the FDA and other global agencies.

PTC Windchill 10.2 also includes new quality related capabilities that help accelerate problem resolution, the company says. This includes tighter integration between quality analyses tools and core change management processes to help improve product quality sooner. The solution expands compliance with existing Conflict Minerals legislation, as the first SEC filing deadline of May 31, 2014, approaches. The solution now manages part-level Conflict Mineral compliance status declarations in addition to existing supplier level Conflict Mineral compliance declarations.

Version 10.2 includes 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 systems. Users can also visually construct manufacturing process plans from the engineering BOM.

“We are pleased to introduce the latest release in the PTC Windchill family, and have worked closely with our customers to deliver the right solution to meet the growing needs of today’s manufacturers” said Mark Hodges, divisional manager, PLM segment, PTC. “PTC Windchill 10.2 focuses on delivering speed and efficiency both to the enterprise, through streamlined compliance, and individual users, through improvements to enhance productivity.”

For more information, visit PTC.

Sources: Press materials received from the company and additional information gleaned from the company’s website.