American Regent Inc. Selects Sparta Systems’ TrackWise Digital QMS to Seamlessly Connect Quality Across Manufacturing, Clinical and Supplier Network

USA pharmaceutical manufacturer upgrades to leading cloud-based quality management system

HAMILTON, N.J. – June 15, 2020 – Today, Sparta Systems, Inc., the leading provider of quality management solutions for life sciences, announced that American Regent, Inc., a top-10 injectable manufacturer, has chosen TrackWise Digital® as its next generation cloud platform for manufacturing, clinical, and supplier management.

American Regent has been a TrackWise® software customer since 2014. With increasing product and supply chain complexity, they needed a digital platform to integrate strategic systems and meet audit, complaint, and CAPA requirements. Sparta’s TrackWise Digital platform provides expanded capabilities to help American Regent grow and adapt to the changing business and regulatory climate, while enabling consistent reporting and compliance to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) across their organization.

In addition, American Regent will leverage Sparta’s Supplier Quality Management solution to collaborate with suppliers, simplify audits and integrate supplier quality events within their QMS.  “We’ve always been proud of our reputation and standards for high quality,” said Nick Walp, American Regent Vice President, Quality Affairs.  “With the upgrade to TrackWise Digital, we can advance our mission of providing Excellence in Quality within our organization and improve traceability throughout our supply chain.”
“Sparta is proud to support American Regent on their digital journey.  As they scale their business, TrackWise Digital will provide excellent visibility of the full quality landscape from clinical to manufacturing,” said Dana Jones, CEO, Sparta Systems.  “We look forward to continuing our partnership as we launch new innovations and advance closer towards a proactive quality model.”
By leveraging TrackWise Transfer℠, an automated solution to migrate their data and configuration from TrackWise to TrackWise Digital, American Regent can minimize risk and costs associated with converting to a new platform.  TrackWise Transfer provides flexibility for their businesses to utilize Sparta’s Quality Process Accelerators while still keeping unique elements of their existing business processes.  This allows American Regent to accelerate their implementation and improve their time to value on the TrackWise Digital platform. 

Sparta’s leading cloud-based TrackWise Digital solution is built on the Salesforce platform and  provides a SaaS model to enable rapid scale and flexibility. Combined with Sparta’s twenty-five years of experience and best practice Quality Process Accelerators, TrackWise Digital helps organizations leverage a robust technology platform to increase efficiency and gain agility to quickly adapt to changing regulatory compliance requirements and patient needs.

About American Regent, Inc.

American Regent, Inc., a Daiichi Sankyo Group company, is a top-10 injectable manufacturer. For over 50 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables for healthcare providers. For nearly 20 years, we have been a leader in IV iron therapy.

American Regent is committed to US-based manufacturing. In 2018, more than 99% of units supplied were manufactured in our US-based facilities, making us uniquely positioned to quickly mobilize and respond to shortages or changes in market needs.

Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.

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About Daiichi Sankyo Group

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

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Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit:

American Regent Media Contact
Terri Ponce