QAD Enterprise Applications Supports Emerging Requirements for Unique Device Identification for Medical Device Manufacturers
QAD ERP Makes it Simpler to Achieve UDI Regulatory Compliance and Ensure Product Integrity from Component to Patient with Backward and Forward Traceability
SANTA BARBARA, Calif.--(BUSINESS WIRE)-- QAD Inc. (NAS: QADA) (NAS: QADB) , a leading provider of enterprise software and services, today announced the enhanced traceability framework in QAD Enterprise Applications supports evolving regulatory requirements for Unique Device Identification (UDI). Manufacturers in the Life Sciences rely on QAD Enterprise Applications to optimize quality control throughout their manufacturing and distribution processes.
The QAD traceability framework equips medical device customers with the tools to manage product integrity across their global healthcare supply chain — from component to product to patient. "QAD customers can accurately track, trace and identify the components and resources — including the items, parts, machines and labor — involved in their manufacturing processes," said Dave Medina, vice president of Life Sciences at QAD. "With QAD's enhanced traceability framework, medical device makers capture real time data to meet the regulatory requirements of UDI."
QAD Enterprise Applications — Tailored to Simplify the Burden of Regulatory Compliance
QAD Enterprise Applications supports manufacturers in achieving regulatory compliance and validation against Current Good Manufacturing Practices (cGMP). In addition QAD supports the upcoming regulations from the United States Food and Drug Administration Amendments Act (FDAAA) for UDI. The law requires manufacturers to label their devices — products ranging from MRI equipment to orthopedics to lab tests and rubber gloves — with a unique identifier to track and trace a product by lot or serial number.
QAD solutions, tailored to simplify the burden of regulatory compliance, allow manufacturers to prepare for similar UDI standards under discussion by the European Commission (EU), the International Medical Device Regulators Forum (IMDRF) and other global agencies. These mandates are all concerned with better managing product traceability, especially post-market safety surveillance, recall management and safety alerts. QAD Enterprise Applications makes it simpler for medical device makers to achieve regulatory compliance and ensure product integrity.
Enhanced Traceability in QAD Enterprise Applications Supports Patient Safety
Patient safety is of critical concern for medical device manufacturers. In the case of an adverse event that leads to a product recall, QAD Enterprise Applications enables customers to efficiently manage and evaluate the effectiveness of a recall. It allows customers to trace a recalled item back to its original manufacturing batch or lot and then forward to locate any potentially affected finished product that is still in inventory or in the supply chain.
Medical device manufacturers are able to better manage quality issues including product complaints, non-conformance reporting (NCRs), audits and CAPAs with QAD Enterprise Applications.
The Effective Enterprise in Life Sciences
"QAD's vision for the Effective Enterprise in Life Sciences is focused on helping our customers manufacture safe and effective healthcare products," added Medina. "We augmented the traceability framework in QAD Enterprise Applications to make it simpler for medical device makers to achieve compliance. Our customers are better able to leverage innovation across their operations with QAD Enterprise Applications."
QAD enables life sciences companies to meet the critical quality requirements for manufacturing innovative, safe and effective healthcare products in compliance with global regulatory standards. QAD incorporates intuitive, easy to use, industry best practices that can be flexibly deployed either onsite or on demand to support global life sciences companies.
For more information about QAD Enterprise Applications, please visit: www.qad.com.
QAD is a leading provider of enterprise applications for global manufacturing companies specializing in automotive, consumer products, electronics, food and beverage, industrial and life sciences products. QAD ERP solutions provide critical functionality for managing manufacturing resources and operations within and beyond the enterprise, enabling global manufacturers to collaborate with their customers, suppliers and partners to make and deliver the right product, at the right cost and at the right time. For more information about QAD, telephone +1-805-566-6000, or visit the QAD web site at 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. Words such as "expects," "believes," "anticipates," "could," "will likely result," "estimates," "intends," "may," "projects," "should," and variations of these words and similar expressions are intended to identify these forward-looking statements. Forward-looking statements are based on the company's current expectations and assumptions regarding its business, the economy and future conditions. 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 software products and products that operate with the company's products; the company's ability to sustain license and service demand; the company's ability to leverage changes in technology; the company's ability to sustain customer renewal rates at current levels; the publication of opinions by industry and financial analysts about the company, its products and technology; the reliability of estimates of transaction and integration costs and benefits; the entry of new competitors or new offerings by existing competitors and the associated announcement of new products and technological advances by them; delays in localizing the company's products for new or existing markets; the ability to recruit and retain key personnel; delays in sales as a result of lengthy sales cycles; 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. In addition, revenue and earnings in the enterprise resource planning (ERP) software industry are subject to fluctuations. Software license revenue, in particular, is subject to variability with a significant proportion of revenue earned in the last month of each quarter. Given the high margins associated with license revenue, modest fluctuations can have a substantial impact on net income. Investors should not use any one quarter's results as a benchmark for future performance. For a more detailed description of the risk factors associated with the company and the industries in which it operates, please refer to the company's Annual Report on Form 10-K for fiscal 2013 ended January 31, 2013, and in particular, the section entitled "Risk Factors" therein, and in other periodic reports the company files with the Securities and Exchange Commission.
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