Terumo BCT Selects Windchill Quality Management to Enhance Global Quality Processes
11 October 2017 - 12:00AM
Business Wire
PTC (NASDAQ: PTC) today 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, analyze, 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
standardize 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.
“With our long-standing commitment to provide continuous
improvements that create quality that delights our customers, we
needed a solution provider with a comprehensive offering, a
scalable architecture, and a commitment to the medical device
market – and we found all of that in PTC,” stated Jayne Odom, VP
Enterprise Portfolio Management, Terumo BCT.
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 maximize patient safety and efficacy while following
best practices for regulated life sciences environments.
“Today’s medical device manufacturers face many complex
challenges and are continuously improving processes and technology
to foster proactive design-based quality management,” said Kevin
Wrenn, divisional general manager, PLM Segment, PTC. “We are
pleased to be supporting Terumo BCT’s ongoing mission to enhance
quality processes so they can provide the highest level of value to
their customers.”
For more than twenty years, PTC has partnered with leading life
sciences companies to advance the state of medical engineering.
Today 27 of the top 30 medical device companies rely on PTC
products to help engineer, manufacture, and service successful
medical products.
Additional Resources
- Harvard Business Review: “How Smart,
Connected Products are Transforming Companies,” authors PTC CEO Jim
Heppelmann and Harvard Professor Michael Porter
- PTC Solutions for Medical Device
Manufacturers
The announcement of a customer’s selection of PTC software is
not necessarily indicative of the timing of recognition of related
revenue or the amount of revenue for any particular period or that
any related applicable implementation and deployment activities are
complete.
About Terumo BCTTerumo BCT, a global leader in blood
component, therapeutic apheresis and cellular technologies, is the
only company with the unique combination of apheresis collections,
manual and automated whole blood processing and pathogen reduction
technologies. We believe in the potential of blood to do even more
for patients than it does today. This belief inspires our
innovation and strengthens our collaboration with customers.
About PTC (NASDAQ: PTC)PTC has the most robust Internet
of Things technology in the world. In 1986 we revolutionized
digital 3D design, and in 1998 were first to market with
Internet-based PLM. Now our leading IoT and AR platform and
field-proven solutions bring together the physical and digital
worlds to reinvent the way you create, operate, and service
products. With PTC, global manufacturers and an ecosystem of
partners and developers can capitalize on the promise of the IoT
today and drive the future of innovation.
PTC.com @PTC Blogs
PTC, Windchill, and the PTC logo are trademarks or registered
trademarks of PTC Inc. or its subsidiaries in the United States and
other countries.
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version on businesswire.com: http://www.businesswire.com/news/home/20171010006022/en/
PTCJack McAvoy, 781-370-6143Corporate
Communicationsjmcavoy@ptc.comorMichelle Hopkins,
678-515-7651mihopkins@ptc.com
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