Thursday Dec 05, 2013

Webcast on 12/19: Enterprise Quality Management and the Product Value Chain

Build a Strong Foundation to Promote Quality Excellence

Although most guiding principles for quality management have remained constant, the past few years have pushed business models to change so dramatically that once-ideal systems are now obsolete. Point quality solutions and siloed directives are not capable of sustaining growth. Business leaders are looking to centralize and extend quality controls to promote excellence enterprise-wide, and they are finding success by building a solid foundation throughout the product value chain.

The product value chain comprises all product data and every related process, so with proper controls embedded throughout, organizations can pragmatically enforce common quality standards across a very wide range of quality initiatives. Join our webcast on Thursday, December 19th at 11:00 a.m. PST / 02:00 p.m. EST featuring industry analyst LNS Research and industry leader GE Healthcare to learn about:

  • How GE Healthcare built a world-class Supplier Quality Management System leveraging Oracle’s Enterprise Quality Management solutions
  • The current enterprise quality landscape and the role of Product Lifecycle Management (PLM) solutions as the core enabler of effectively managing quality processes from “insight to action”
  • Top challenges and best practices for executives considering Enterprise Quality Management solutions
  • Benefits such as risk reduction and sustainable growth through fast, efficient problem resolution and corrective action

Speaker Information

Mark Bienkowski, Global Manager, Supplier Quality Process and Audits,
GE Healthcare

As the Supplier Quality Process and Audits Manager, Mark is responsible for the GE Healthcare global purchasing controls systems and compliance. He also leads teams of Process Lean Leaders and Supplier Auditors who ensure clear and concise quality collaboration between GE Healthcare and its supply base. Mark also has experience in information technology, manufacturing engineering, new product development, and quality assurance. Mark attended Bucknell University where he graduated with a Bachelor of Science degree in Mechanical Engineering.

Matthew Littlefield, President and Principal Analyst
LNS Research

Matthew Littlefield founded LNS Research in August of 2011 and is now president and principal analyst. Littlefield covers the topics Enterprise Quality Management Software, Manufacturing Operations Management, Asset Performance Management, Sustainability, and Industrial Automation 2.0. Before founding LNS Research, he spent five years as senior analyst for the Aberdeen Group and led the Global Manufacturing Research practice. Before that, he worked for multi-billion dollar manufacturers (Unilever, HP Hood) in both engineering and shop-floor management roles. He graduated cum laude from the University of Massachusetts, Amherst with a BA in Economics and MS in Industrial Engineering and Operations Research.


Register Today

Monday Sep 16, 2013

Oracle's Unique Device Identifier Solution: A 3-Step Approach to FDA Compliance

By Todd Hein, Senior Director of Life Sciences, Oracle

In 2007, the Food and Drug Administration Amendments Act was signed to improve patient safety by improving the flow of information on medical devices. This legislation is anticipated to be enforced within the next 12-18 months and, at minimum, requires Class II and Class III medical devices distributed in the U.S. to carry a Unique Device Identification (UDI), a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information.

The FDA's vision for the UDI system is to provide global visibility and support the following improvements in the medical device processes:

  • Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
  • Provide a standardized identifier that will 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 and diversion and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

In order to help medical device companies to streamline the process and achieve UDI compliance in the short timeline available, Oracle has announced the 3-Step UDI Solution that combines enhanced business processes with data capture to achieve UDI compliance at a low total cost of ownership. Keeping with the theme of simplicity, the comprehensive Oracle solution achieves UDI compliance in three simple steps:

  1. Source, cleanse and validate legacy UDI attributes for each shippable SKU
  2. Process and manage UDI, Global Trade Information Number (GTIN) and SKU hierarchies
  3. Extract and submit accurate data to the Global Unique Device Identification Database (GUDID) and Global Data Synchronization Networks (GDSNs)

To develop the 3-Step UDI solution, Oracle worked closely with the FDA to gain a better understanding of the requirements, and also worked directly with the several leading medical device companies to ensure specific business challenges were addressed. Through a partnership with Inspirage, an Oracle Platinum Partner; the resulting solution provides a "Rapid Start" template approach to ensure that the aggressive FDA deadlines can be met.

The value of deploying this solution is not just limited to meeting FDA compliance mandates. With the underlying technology in the Oracle UDI solution, medical device companies have a strong foundation to expand parallel business processes across the enterprise for compounding business benefit.

The 3-Step UDI Solution demonstrates Oracle's commitment to addressing the unique requirements of the medical device industry. Combining industry knowledge with a comprehensive product line and partner expertise, Oracle is well-positioned to create valuable solutions to assist all medical device companies.

To learn more about the Oracle 3-Step UDI Solution, click here.

 

Wednesday Jul 24, 2013

New On-Demand Webcast: How Leading Brands Use Product Quality as a Differentiator

Last week Oracle and Kalypso jointly held a webcast showcasing some of the inspiring ways companies leverage Agile Product Lifecycle Management applications as a foundation for comprehensive Enterprise Quality Management.  If you happened to miss it, don't fret!  The webcast is now available On-Demand.   

Why should you watch this webcast? 

Product quality is a powerful differentiator: surveys consistently prove it is a top influence in consumer buying decisions. And since technology has made quality ratings so easily accessible to the market, companies are under increasing pressure to ensure the highest possible quality and to resolve issues quickly. But many companies are not fully equipped to manage this dynamic. Is your organization prepared to confidently design quality and compliance into your new products, and quickly access, analyze and resolve problems when they surface anywhere in your value chain? To prevent poor quality from affecting great products, leading brands take a comprehensive approach to managing both supplier and product quality, deploying Product Quality Management (PQM) solutions as a part of their overall Product Lifecycle Management (PLM) roadmap. Please take a moment to watch this On-Demand Product Quality Webcast with speakers Joe Erickson of Oracle and Fred Brown of Kalypso featuring an informative discussion on how Agile PLM and PLM for Process can help your company prepare for and manage your product quality and regulatory requirements.

There's even a special offer included in the webcast... watch it today to find out! 

Monday Jan 09, 2012

Quantum Corporation Accelerates Time to Market and Reduces Costs with Product Lifecycle Management Applications

This article is a reprint of the Quantum Corporation case study on the Oracle Customer Showcase. [Link]

Quantum Corporation is a proven global expert in data protection and big data management that provides a unique combination of intelligent storage solutions and unmatched value for traditional, virtual, and cloud environments. These solutions include DXi®-Series disk-based deduplication and replication systems for fast backup and restore, Scalar® tape automation products for disaster recovery and long-term data retention, StorNext® data management software and appliances for high-performance file sharing and archiving, and vmPRO™ solutions for protecting virtual machine data.

To accelerate product innovation and time to market for new storage products and upgrades, Quantum wished to upgrade its lifecycle management applications for streamlined engineering, production, and compliance processes, as well as enhanced collaboration with employees and partners. Quantum also looked to reduce development and production costs, improve information accessibility, and streamline compliance reporting.

After reviewing various vendors, Quantum implemented Oracle’s Agile product lifecycle management applications and granted access to approximately 1,500 users. With the implementation, Quantum reduced engineering and production change time from weeks to days or hours. The company also reduced costs by minimizing order cancellations or inventory issues as well as enhancing employee and partner collaboration for engineering and manufacturing processes. Finally, Quantum used Agile Product Governance and Compliance to respond to customer and governmental reporting requirements and to maintain an information library.

Challenges

  • Accelerate product innovation and time to market for new storage products and upgrades, such as deduplication and replication systems, and optimize patent value in the competitive data storage market
  • Reduce development and production costs to meet market requirements and handle increasing global data volumes, as well as capture a competitive edge
  • Increase scalability in product lifecycle management capabilities and enhance engineering collaboration with partners and employees
  • Streamline and accelerate compliance reporting required by customers and regulatory organizations, such as U.S. customs and trade regulations
  • Improve information accessibility for employees, administrators, and partners

 Solutions

  • Deployed Oracle’s Agile product lifecycle management applications to approximately 1,500 users to streamline engineering, production, and compliance processes, enhance collaboration, and accelerate product time to market. The applications include Agile Product Collaboration, Agile Product Quality Management, and Agile Product Governance & Compliance.
  • Accelerated engineering and production changes—with changes that used to take weeks, now taking only days or hours
  • Reduced costs with improved employee and partner collaboration for engineering and manufacturing processes
  • Decreased order cancellation and inventory issue costs as data can be shared quickly with production facilities
  • Implemented Oracle’s Agile Product Governance and Compliance to enable the company to respond to customer and governmental reporting requirements regarding product content and to maintain a library of this information
  • Integrated the company’s Agile and Oracle E-Business Suite applications to eliminate time-consuming, manual data reentry and reduce the errors and costs associated with rekeying data

A word from Quantum Corporation

“Oracle Agile product lifecycle management applications enable us to collaborate and communicate globally with employees and partners. With the implementation, we acquired enhanced information-sharing capabilities to accelerate time to market, improve reporting capabilities, and reduce costs.” – Daniel Hartley, Product Lifecycle Management Applications Manager, Quantum Corporation

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