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Systech International and Tata Consultancy Services Partner to Help Medical Device Manufacturers Comply with UDI Legislation

Systech International, a global leader in enterprise serialization and track & trace solutions, today announced its partnership with Tata Consultancy Services (TCS), a provider of world-class IT services and business solutions, to supply medical device manufacturers with a means of complying with pending FDA Unique Device Identification (UDI) requirements.

Part of UDI rule establishes that each model or version of a medical device should be assigned a Unique Device Identifier and a part of this information be reported to the FDA Global Unique Device Identification Database (GUDID) where it is accessible to the public.

Systech and TCS have jointly developed an end-to-end UDI solution which addresses Master Data Management (MDM), System of Record for UDI, and Interface with labelling solution at the packaging lines. The solution works by integrating different data sources to create a single platform on which manufacturers can maintain and locate master device identifier information. The platform then transmits this information to GUDID, ensuring manufacturer compliance.

In addition to managing device identifier information, the platform can be extended to individual manufacturing sites where it can be used to manage the assignment and application of Unique Production Identifiers to devices and device packaging.

“The TCS-Systech UDI platform not only offers manufacturers a means of meeting initial device identifier reporting requirements, but as importantly, a centralized platform that can manage production identifier data throughout an enterprise,” said Barry McDonogh, VP Business Development at Systech.

Regu Ayyaswamy, Global Head - Engineering and Industrial Services, TCS said, “The TCS-Systech UDI solution provides a unified platform to medical device manufacturers with traceability throughout the supply chain. Medical devices and diagnostics customers can benefit from TCS’ global presence for enterprise-wide UDI solution implementation, covering their global facilities.”

About Systech International

Systech International is a global leader in brand protection technologies with solutions that address the needs of enterprise serialization, track and trace, and authentication, serving a wide variety of industries ranging from pharmaceutical and medical devices to food and beverage and consumer goods. To learn more about Systech, please visit www.systech-tips.com

About Tata Consultancy Services Ltd. (TCS)

Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT, BPO, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery Model™, recognised as the benchmark of excellence in software development. A part of the Tata group, India’s largest industrial conglomerate, TCS has over 300,000 of the world’s best-trained consultants in 46 countries. The company generated consolidated revenues of US $13.4 billion for year ended March 31, 2014 and is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit www.tcs.com.

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