QAD ERP Makes it Simpler to Achieve UDI Regulatory Compliance and Ensure Product Integrity from Component to Patient with Backward and Forward Traceability
<0> QAD Enterprise Applications Supports Emerging Requirements for Unique Device Identification for Medical Device Manufacturers </0>
<0> QAD Inc.Ashley DeVan, +1-805-566-6126Sr. Director of Marketing CommunicationsorQAD Inc.Heidi Wieland, +1-805-565-2452Media Relations </0>
. (NASDAQ:QADA) (NASDAQ:QADB), a leading provider of , today announced the enhanced traceability framework in supports evolving regulatory requirements for (UDI). in the rely on QAD Enterprise Applications to optimize quality control throughout their manufacturing and distribution .
The QAD traceability framework equips with the tools to manage 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.”
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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 (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 , tailored to simplify the burden of regulatory compliance, allow manufacturers to prepare for similar UDI standards under discussion by the European Commission (), the International Medical Device Regulators Forum () 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.
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 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.
“QAD’s vision for the 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 to support global life sciences companies.
For more information about QAD Enterprise Applications, please visit: .
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 .
“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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