QAD Prepares Unique Device Identifier Compliance Solution for Medical Device Manufacturers
QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB) , a leading provider of cloud enterprise resource planning (ERP) solutions and services for global manufacturers, announced today it has developed a solution for medical device manufacturers to help meet the Unique Device Identifier (UDI) rules as required by the Food and Drug Administration (FDA).
The FDA issued a rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier, except where the rule provides for an exception or alternative placement. The labeler must also submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID). The first phase of the UDI requirements applies to class III devices and requires that they display the UDI label by September 24, 2014. The UDI labels include a device identifier, which consists of the labeler and specific model of the device, and a production identifier that includes lot or batch numbers, expiration date and other valuable information.
When fully implemented, the UDI system will:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports.
- Reduce medical errors by enabling health care professionals to rapidly identify a device.
- Enhance analysis of devices on the market by providing a standard way to document device use in electronic health records, clinical information systems, claim data sources and registries.
- Provide a standardized identifier to allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting.
“We are pleased to offer life science product manufacturers a solution for the FDA’s Unique Device Identifier requirements,” stated QAD Life Sciences Director of Marketing Bart Reitter. “Meeting the UDI rule is extremely important for the life science industry. Our customers are well prepared to meet this mandate with an effective, integrated solution.”
About QAD – The Effective Enterprise
QAD Inc. (NASDAQ:QADA) (NASDAQ:QADB) is a leading provider of enterprise software and services designed for global manufacturing companies. For more than 30 years, QAD has provided global manufacturing companies with QAD Enterprise Applications, an enterprise resource planning (ERP) system that supports operational requirements, including financials, manufacturing, demand and supply chain planning, customer management, business intelligence and business process management. QAD Enterprise Applications is offered in flexible deployment models as on-premise software, in the cloud with QAD Cloud ERP or in a blended environment. With QAD, customers and partners in the automotive, consumer products, food and beverage, high technology, industrial products and life sciences industries can better align daily operations with their strategic goals to meet their vision of becoming more Effective Enterprises.
For more information about QAD, call +1 805-566-6000, visit www.qad.com.
“QAD” is a registered trademark of QAD Inc. All other products or company names herein may be trademarks of their respective owners.
Note to Investors: This press release contains certain forward-looking statements made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding projections of revenue, income and loss, capital expenditures, plans and objectives of management regarding the Company’s business, future economic performance or any of the assumptions underlying or relating to any of the foregoing. Forward-looking statements are based on the company’s current expectations. Words such as “expects”, “believes”, “anticipates”, “could”, “will likely result”, “estimates”, “intends”, “may”, “projects”, “should”, “would”, “might”, “plan” and variations of these words and similar expressions are intended to identify these forward looking statements. A number of risks and uncertainties could cause actual results to differ materially from those in the forward-looking statements. These risks include, but are not limited to: evolving demand for the company’s products and companion products; the ability to sustain license and service demand; fluctuation in revenue and earnings in the software industry; the ability to leverage changes in technology; the ability to sustain customer renewal rates at current levels; third party opinions about the company; the reliability of estimates of transaction and integration costs and benefits; competition in our industry; delays in localizing the company’s products for new or existing markets; the ability to recruit and retain key personnel; delays in sales; changes in operating expenses, pricing, timing of new product releases, the method of product distribution or product mix; timely and effective integration of newly acquired businesses; general economic conditions; exchange rate fluctuations; and, the global political environment. For a more detailed description of the risk factors associated with the company, please refer to the company’s latest Annual Report on Form 10-K, and in particular, the section entitled “Risk Factors” therein, and in other periodic reports the company files with the Securities and Exchange Commission thereafter. Management does not undertake to update these forward-looking statements except as required by law.
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