QAD Enterprise Applications Makes it Simpler for Pharma and Biotech Companies to Ensure Drug Authent
QAD Enterprise Applications Makes it Simpler for Pharma and Biotech Companies to Ensure Drug Authenticity and Safety
QAD Customers Rely on QAD ERP to Help Ensure Quality By Design Throughout their Multi-Regional Manufacturing Processes
SANTA BARBARA, Calif.--(BUSINESS WIRE)-- QAD Inc. (NAS: QADA) (NAS: QADB) , a leading provider of enterprise software and services, today announced its enhanced quality control framework in QAD Enterprise Applications makes it simpler for Pharma and Biotech companies to ensure drug authenticity and product safety. Manufacturers in the Life Sciences industry rely on QAD Enterprise Applications to support quality-by-design throughout their global manufacturing processes.
QAD Enterprise Applications simplifies the way customers can embed quality control processes throughout their production and business operations to meet government imposed regulations while driving innovation.
"QAD customers can track, trace, identify and authenticate prescription products to the smallest saleable unit level," said Dave Medina, vice president of Life Sciences at QAD. "QAD Enterprise Applications makes it simpler for customers to ensure their products meet their quality standards across their manufacturing processes while gleaning insights into how products and processes can be enhanced for greater efficiency and efficacy."
QAD Allows Customers to Embed Quality Framework with Every Link in their Supply Chain
Using QAD Enterprise Applications, customers can support drug ePedigrees - electronic records which trace each drug's chain of ownership from the pharmacy back to the manufacturer. The embedded quality framework in QAD Enterprise Applications is designed to provide complete visibility into the transactional history of a drug or drug lots. It offers comprehensive, centralized reporting and archival history for compliance and exception management. By embedding traceability into the manufacturing process, as opposed to adding serialization to a finished product, QAD's enhanced quality framework provides companies with visibility across all aspects of their product manufacturing processes. Additionally, QAD enhanced traceability capabilities can link product and manufacturing processes with business transactions across the supply chain including purchase orders, ship notices, and invoices. This can increase supply chain visibility, enhance process optimization and in the case of an adverse event - support effective recall management.
The enhanced controls and audit capabilities, along with eSignature support from QAD, allow companies participating in the Pharmaceutical Supply Chain to meet regulatory requirements such as the Federal Prescription Drug Marketing Act (PDMA). The fully embedded quality framework in QAD Enterprise Applications offers Biotech and Pharma companies and packagers a complete solution to boost supply chain management. By using their enterprise resource planning (ERP) system to enforce the integration of a quality framework into their operations, life sciences companies can ensure the consistent, regulatory compliant execution of their business processes without the disruption of third-party or paper-quality systems.
Product Diversion and Drug Counterfeiting
An effective enterprise in the life sciences industry thrives on delivering innovative, quality products that help improve patients' lives. QAD's enhanced quality framework is designed to support drug authenticity and safety with track and trace capabilities that can also support measures to detect product and public safety issues. The growing global problem associated with counterfeit drugs, including those sold with a false brand name, generates an estimated $75 billion in revenue annually, according to The National Association of Boards of Pharmacy. To date, governments have struggled to safeguard the distribution of legitimate drugs and crack down on counterfeits.
RXfor Mitigating Risk
In the United States, California has been leading the charge with their ePedigree law due to take effect in 2015, which may prevent the diversion or counterfeiting of drugs by requiring the serialization and ePedigree of pharmaceutical drug packages. European regulations, too (in Turkey, France, and elsewhere) are focused more on product authentication, and are driving companies to pursue item-level serialization. Until effective public policy is implemented, the pharmaceutical industry can move towards compliance by implementing authentication capabilities such as those offered by QAD Enterprise Applications.
QAD assists life sciences companies in meeting 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.
"QAD's vision for the Effective Enterprise in Life Sciences is focused on helping our customers manufacture safe and effective healthcare products," added Medina.
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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