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Massachusetts, US: PTC has announced that Terumo BCT has selected the Windchill Quality Management solution to support the company’s continuous improvement initiatives for quality systems and processes around the world.

Terumo BCT, a medical technology company, holds a global leadership position in blood component, therapeutic apheresis, and cellular technologies. The company is dedicated to improving the efficiency of blood and cellular therapies, along with clinical and patient outcomes.

Windchill Quality Management will support Terumo BCT’s various quality systems and its mission to ultimately provide the highest level of value to its customers throughout the world. The software system will enable the company to track, analyse, and use essential inputs to continually improve product design, quality control, training, and supply chain issues.

Windchill Quality Management enables medical device manufacturers to address Product Lifecycle Management (PLM) and Quality Management System (QMS) functions in a single system. It includes best-practice configurations purpose-built for medical device manufacturers. The solution allows medical device makers to standardise on quality management best practices, reduce regulatory overhead, and share quality and engineering intelligence.

Terumo BCT chose Windchill based on the strength of its Quality Management System (QMS) and Document Control (DC) capabilities. With this unified solution, Terumo BCT can triage and adjudicate customer complaints to ensure that external sources for quality issues are accurately managed for rapid correction and prevention. The company also plans to deploy PTC’s CAPA and Nonconformance (NC) Management modules as part of the integrated platform.

To meet the FDA CfQ initiative, medical device companies need technology that enables industry best practices for Design Control, Document Control, Nonconformance Management (NC), Complaint Management (CEM), Corrective and Preventive Action (CAPA), Risk Management, Audit Management and Unique Device Identification (UDI). PTC’s solution provides all of these capabilities in one platform and is harmonized for ISO 13485, FDA TPLC and 21 CFR Part 820 regulations. It provides medical manufacturing companies with proactive, high-quality and fully traceable product development processes. With pre-configured, out-of-the-box best practices designed for life sciences companies, PTC solutions enable companies to maximise patient safety and efficacy while following best practices for regulated life sciences environments.




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