HeartWare ERP System Live and Validated in Just Six Months

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Heart Pump Technology Developer Chooses Strategic Information Group to Ensure Successful ERP Upgrade

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We highly recommend Strategic Information Group to any company considering implementing or upgrading QAD ERP

Strategic Information Group (Strategic), a full service provider of enterprise technology, quality and regulatory management solutions, announced today that medical device maker HeartWare International, Inc. (HeartWare) has successfully gone live, on time and on budget, with QAD Enterprise Applications 2009 Standard Edition (QAD 2009 SE) with QAD .NET UI user interface.

HeartWare is developing a family of implantable Left Ventricular Assist Devices ("LVADs") for the treatment of advanced heart failure. The HeartWare Ventricular Assist System has received CE Marking in the European Union and is currently undergoing clinical trials in the United States. The company's corporate headquarters are in Framingham, Massachusetts; its operating and manufacturing activities are based in Miami Lakes, Florida.

With the company's European market launch and its expanding clinical development in the United States, HeartWare wanted to ensure that it had the right enterprise technology in place to keep its operations and processes at top performance. HeartWare called on Strategic as its enterprise technology partner to upgrade its enterprise applications system from QAD eB2.1 to QAD SE 2009. Strategic also provided validation tools and services. From inception to go-live the project took just six months.

"Strategic Information Group's depth of QAD knowledge, manufacturing best practices and the diligence of our Project Manager Keith Randazzo enabled this significant undertaking to be completed on an impressive timeline and within budget," said Michael Webb, Director of Operations Engineering for HeartWare.

QAD's .NET UI has helped HeartWare speed the learning curves for employees and enhance user effectiveness and productivity. QAD's Reporting Framework has improved the speed and accuracy of reporting processes and eliminated the need for third party forms.

"During the upgrade we took advantage of the opportunity to optimize HeartWare's business processes to improve efficiencies and minimize errors," said Webb.

Re-engineering processes to streamline them and apply best practices is already delivering greater operational efficiencies. With enhanced data accuracy and reporting capabilities, HeartWare has also been able to drive significant improvements in order processing and operations reporting.

"With QAD 2009 SE, HeartWare can stay focused on bringing its vital technology for the treatment of heart disease to market quickly and efficiently, while meeting regulatory requirements and managing risk," said Doug Novak, President and CEO of Strategic.

"We highly recommend Strategic Information Group to any company considering implementing or upgrading QAD," said Webb. "Strategic addressed our desire for rapid progress and their team approach helped make the significant task of upgrading our ERP system while re-engineering our processes an enjoyable challenge for the HeartWare team."

Strategic provides consulting services in support of QAD applications to companies looking to better leverage their ERP investment. Strategic also offers specialized software validation products; the company's Validation Toolkit helps with FDA CFR 21 Part 11 validation requirements, streamlining validation for regulatory compliance, and allowing companies to implement and upgrade QAD applications with speed and ease.

QAD Enterprise Applications enable life sciences manufacturers to optimize operations, meet compliance requirements, manage product quality and create market opportunities. QAD 2009 SE is a comprehensive, fully integrated end-to-end solution that delivers robust functionality, essential compliance capabilities, better organizational efficiency and enhanced usability.

About Strategic Information Group
Strategic Information Group (Strategic) helps companies achieve their corporate goals with the application of enterprise technology. The company specializes in providing proven solutions for a full range of enterprise applications including ERP, CRM, and QMS. Strategic works with start-ups, multinationals and market leaders to implement their systems on time and on budget, helping them maximize the value of their enterprise technology. For more information visit about Strategic, telephone +1 760-697-1050 or visit the Strategic website at http://www.strategic.com.

"QAD" is a registered trademark of QAD Inc. All other products or company names herein may be trademarks of their respective owners.

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Shaw Coates
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