Latest release of PTC Windchill reduces effort needed to comply with new FDA and SEC regulations; enhances integration with PTC Integrity
NEEDHAM, Mass. — (BUSINESS WIRE) — September 17, 2013 — PTC (Nasdaq: PMTC) today announced the availability of the latest release of PTC Windchill® product lifecycle management (PLM) software. PTC Windchill 10.2 adds capabilities to help manufacturers improve productivity and streamline compliance with new government regulations.
With FDA regulated Unique Device Identification (UDI) compliance set to take place during 2014, medical device manufacturers need a solution that will reduce the effort needed to comply with the law. The regulation specifically mandates that every unique product, product version, and product configuration be assigned a UDI to be prominently displayed on its labeling.
In requiring medical device manufacturers to provide UDI-compliant labeling, the new regulation presents them with the significant challenge of efficiently handling the vast amounts of data required for UDI-compliant submissions for each and every product, including unique product versions, variants, configurations, and packaging.
As a result, PTC has developed a preconfigured, out-of-the-box technology solution, PTC UDI, to provide for the complete management and traceability of UDI data while retaining the flexibility needed to scale to future regulatory and product development changes. This includes:
- Collecting and Managing key UDI data from multiple data stores
- Automating 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;
- Streamlining 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 many new quality related capabilities that help accelerate problem resolution. This includes tighter integration between powerful quality analyses tools and core change management processes to help improve product quality sooner – lowering the potential need for costly rework and customer issues.
PTC Windchill 10.2 expands compliance with existing Conflict Minerals legislation, as the first SEC filing deadline of May 31, 2014 fast approaches. PTC Windchill 10.2 now manages part level Conflict Mineral compliance status declarations in addition to existing supplier level Conflict Mineral compliance declarations. As a result, 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.
Within PTC Windchill 10.2 users can:
- Visually interrogate data relationships – This release enables improved productivity by easily understanding the relationships between different product elements – including change requests and manufacturing process plans - using graphical flowcharts. This relationship navigation also extends to objects and requirements created using PTC Integrity™ application lifecycle management software.
- Share product configuration options with ERP – This release ensures that the same configuration rules are enforced across both PLM and ERP systems.
- Visually construct process plans – PTC Windchill 10.2 enables increased efficiency by visually constructing – including building and playback – manufacturing process plans from the engineering BOM. Manufacturing engineers can easily create the process plan, using engaging visual tools that provide feedback to enable them to ensure all parts have been accommodated and the chance for errors has been reduced.
“This release adds 'See More' to PTC's ‘Do More, Know More, Get More' focus,’” said industry analyst Monica Schnitger, Schnitger Corp. “By adding visual process planning, graphical relationship explorer and streamlined document management capabilities, PTC Windchill 10.2 gives users a clear, concise view into all aspects of the product lifecycle.”
“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.”
- PTC Windchill 10 Upgrade - Resource Center
- Unique Device Identification Requirements for Medical Devices
- PTC Conflict Minerals Compliance
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