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)

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.”

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

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

Media:Systech InternationalorMedia
or for more information for companies interested in joining the
partnership program:Tata Consultancy Services

Source: Systech International