Roche Diagnostics is a leading manufacturer of Glucose Monitoring Strips and Diabetes Care products. This regulated manufacturing environment is filled with unique obstacles that require intense monitoring and control, in addition to business initiatives such as Lean and Quality improvements.

This presentation will provide a strategic look at how Camstar Manufacturing MES enables our Lean and Quality initiatives in hybrid (batch and discrete) operations. We will highlight key drivers for the return on the investment, including what Lean does for the company in terms of product quality, higher output, and cost reductions; and explain how Camstar Manufacturing (including Weigh and Dispense) provides the foundation for these initiatives. We will include real-world solutions and scenarios that systematically support these initiatives, helping stakeholders envision their realized and future potential ROI.

NP Medical develops and produces reliable, efficient drug and fluid access devices and components for the OEM healthcare market. Product quality (with a small “q”) is top of mind to the entire organization, not just the Quality department.

A key enabler is the Camstar Enterprise Platform, which helps us clearly understand our processes in real time, proactively enforce good practices to prevent problems, discover which parameters should be prioritized for monitoring, capture and analyze events that are potential CAPA sources, transform data into information required for effective root cause analysis, and continuously improve processes and new product designs. This cycle of prevention - analysis – improvement results in higher customer confidence and satisfaction.

We will show in a case study:

• How we used strategic advantage in addition to ROI to justify the project
• The rationale behind our project priorities and sequencing, including MES, process controls, data historian, event management, analytics and CAPA
• Examples of what we’ve learned about processes, equipment and product designs
• Specific benefits of the quality (with a small “q”) approach

Enterasys Networks, a Siemens Enterprise Communications Company, is a premier global provider of wired and wireless network infrastructure and security solutions. At Enterasys, our culture and all aspects of our operations are built around the mantra that “There is nothing more important than our customers.” SigmaSure has helped us to take care of our customers by having data available from multiple sources, including our contract manufacturers and other suppliers.

Enterasys products are 100% outsourced which requires constant monitoring of our CMs and ODMs around the globe to ensure our customers receive the best quality products. Camstar’s SigmaSure SaaS provides the framework and analytical tools to operationalize the communication, and helps identify areas of improvement. In this presentation we will show you how Enterasys implemented SigmaSure with CMs and ODMs in China, Taiwan, and Thailand. We will review the methods used to bring CMs on board, our learnings from having access to detailed data from manufacturing, and our next steps toward continuous improvement.

Beyond finance, there's no one function in business other than quality that touches more organizational functions or the bottom line. Quality’s role is shifting. It no longer represents just the product, but delivery of profitable, total customer value. Leading companies are removing the walls that have isolated quality as a function and are now embedding it as an end-to-end organizational competency. In this session Gartner will share findings and best practices for companies to successfully elevate quality’s role in their value chains.

Terumo has adopted a closed-loop approach to product quality – rather than focusing only on their traditional compliance-focused processes – and is able to drive more business value from: Good quality processes, early detection and prevention of issues, the visibility to quickly find and correct root causes, and enforcement to drive consistency across all plants.

In this session you will learn:

• Characteristics of a low-risk, high quality operation
• How to turn FDA regulations into an impetus for proactive business decisions that enable higher product quality, growth and profitability
• How Terumo's Platform approach with MES, QMS and Intelligence enables this continuous improvement
• Specific positive business results of embracing a closed-loop approach
• Recommendations for manufacturers in any industry on how to view quality from the customer perspective

Waters Corporation is a leading global manufacturer of high-performance analytical technology. Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

We employ a mix of in-house and contract manufacturing at several locations worldwide and purchase high volumes of components. Managing complex multi-level bills of material with thousands of components and synchronising revision changes to SigmaSure Genealogy requires an intelligent and automated process. In this session we will describe how we are implementing integration between Camstar SigmaSure and SAP PLM to:

• Build and maintain BoM structures within SigmaSure Genealogy including detailed part level attributes
• Acquire and record part-level data such as manufacturing process information, process results, genealogy, engineering changes and deviations
• Generate the as-built and as-maintained structure of our instruments
• Link qualification, test and process data with the genealogy structure of the instrument and the performance of its components and subassemblies
• will also describe our process for the validation of this automated process with regard to medical device products before it is put into service

3M Unitek is a leading manufacturer of Orthodontic Products, manufacturing over 14,000 products and selling to over 50,000 customers globally. Typical monthly production is over 10,000 lots and domestic customers expect product to arrive in 1-2 days. As with many manufactures, it is imperative that we maintain top customer service while reducing manufacturing costs and inventory dollars.

This presentation will describe an innovative solution of how 3M Unitek is meeting these objectives with the aid of "Visual Management." Included will be a discussion on how the system utilizes real-time production, service, inventory, and cycle time data, enables visual management and supports lean manufacturing initiatives throughout the plant. As a result, personnel at all levels are now aware of and motivated by how the business is meeting its goals.

Agilent Life Sciences and Chemical Analysis provides the world’s most complete, most reliable laboratory productivity solutions, optimized for applications and workflows. Through a combination of industry-leading instruments, accessible scientific expertise, easy-to-use software and a full range of global support services, Agilent is able to deliver better results, faster.

In this presentation, Agilent will share how its Life Sciences Group leverages Camstar to enable efficient manufacturing and high product quality where complex custom orders drive the business. Special focus will be on how operations embrace the solution to focus on the imperative perfect order fulfillment.

Agilent has been using Camstar solutions for more than 10 years, and during that time has benefited from it approach to continuous improvement of the implementation.

You will learn:

• How Agilent’s custom-order business affects manufacturing
• The importance of Camstar Manufacturing in ensuring effective change management, process transparency, accurate production and timely delivery
• The implementation philosophy that starts with design of output, and includes automated integration to prevent errors
• Certification and validation methodology for ISO and FDA
• Actual benefits, such as improved order fulfillment, higher manufacturing efficiency, increased revenues and market share

Carl Zeiss Meditec is an integrated medical technology company that offers complete solutions in the field of ophthalmology for treating the four main eye ailments: vision defects (refraction), cataract, glaucoma and retinal disorders.

Delivering new products and greater volumes are constant demands on operations. In order to maintain top quality while maximizing output we focus on reducing variability in our lean operations. In this session we will describe how we employ processes, people and technology to continuously improve by:

• Taking the first step to control and reduce variability
• Understanding the key measure – cycle time - in a lean implementation
• Analyzing specific product cycle time and factors that affect its variation
• Taking action and measuring its effectiveness

We will show an example of implementing lean in a product line, how we analyzed the variables affecting cycle time, and the actions we took to reduce the variability. We will conclude with the actual measurable results of the program.

The globalization of manufacturing and supply of medical and high tech products has created unique and demanding challenges for the manufacturing industry, as well as regulatory bodies like the U.S. Food and Drug Administration. Industry and regulators are preparing to take significant steps to secure the Global Supply Chain.

An example of a significant regulatory move is that the FDA emphasizes brand owners’ full responsibility for all outsourced components and manufacturing that contribute to their products.

Join us to learn the key findings of the Axendia's research on this subject, including:

• The current state of Global Supply and Value chains
• The desired state of Life Science and related industry supply chains
• Key challenges facing global and outsourced ecosystems
• Innovative strategies and technologies to enable and guide this transformation
• Recommendations and a roadmap to achieve Global Supply Chain Visibility and control

Camstar SigmaSure V7 is the next generation of On-demand Supply Chain Quality, encompassing visibility and real-time manufacturing process intelligence, driving supplier and contract manufacturer quality and preventing costly rework and scrap downstream. See how SigmaSure helps you effectively monitor your product across the value-chain – from suppliers to manufacturing, from finished goods to end users, from design to field service.

SigmaSure is delivered - and will be demonstrated - as Software as a Service (SaaS), requiring no hardware or software installation. See for yourself how you can be up and running with suppliers, contract manufacturers or return centers in 4-6 weeks.

dpiX is the world’s leading source for high resolution amorphous silicon sensor arrays. In 2007, dpiX selected the Camstar platform for the start-up of a Gen4 flat panel fabrication plant in Colorado Springs, Colorado. Camstar has been instrumental in meeting the sometimes diametric goals of a start-up.

This presentation will demonstrate how the Camstar system at dpiX connects business functions with the automation of a complex manufacturing environment where production tools have varying, custom interfaces. By leveraging the flexibility and extensibility of Camstar, dpiX now has a system that meets the real-time demands of both business and engineering users, and supports real-time decisions at all levels in a world-class flat panel manufacturing environment.

BIOTRONIK is one of the world’s leading manufacturers of medical products for the electrotherapy of the heart and vascular intervention. This presentation will provide deep insight into how this vertically integrated medical device company has integrated shop floor equipment with Camstar Manufacturing, provided visualization of the manufacturing processes and results, and created the optimal underlying IT platform.

We will describe:

• The benefits of automated data collection approaches using Camstar Open Adapter and Camstar Client Library
• The different methods of visualization for operations, engineering and management – such as business intelligence, parametric analysis and performance dashboards
• The underlying IT platforms, and best practices and lessons learned in supporting a mission-critical, 24x7 global operation

SanDisk Corporation designs, develops and manufactures data storage solutions using flash memory, controller and firmware technologies, and is the world’s leading supplier of innovative flash memory data storage products.

The presentation will describe SanDisk’s adoption of a closed-loop approach to quality. You will learn how we created a seamless information infrastructure that is moving the organization beyond a state-of-the-art manufacturing execution system to a platform that also includes built-in quality management, statistical process control and operational intelligence.

Far from being a minor detail in a company’s overall strategy for success, ensuring good product quality is a defining requirement for leading companies. In this session we will describe seven ways that two successful companies have improved product quality and reduced costs while transforming their global supply chain into a real-time operation. The more problems you identify early and prevent, the quicker product quality improves. Join us to learn how the manufacturers work with their suppliers and contract manufacturers to:

1. Automate gathering of critical supplier data
2. Monitor critical components – discovering issues before shipment
3. Leverage PLM, use deviations, purges, production alerts and stop ships to determine exposure to potential problems
4. Leverage CAPA/CLCA for all internal and external concerns
5. Analyze supplier manufacturing test yield, decreasing escape rates due to poorly optimized tests
6. Use supplier scorecards to proactively improve quality and product performance with critical suppliers
7. Implement supplier improvement programs to objectively improve or disqualify poor performing suppliers

As a result the companies achieved outstanding financial benefits and improved product quality:

• Improved product reliability 30% after one year in service
• Reduce product costs at the contract manufacturer, decreasing product costs by 20%
• Reduced returns by 2% of revenue
• Saved $2M in one incident by avoiding a costly recall
• And more!

Covidien is a leading global healthcare products company that manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies.

This presentation will show how Covidien implemented Camstar's statistical process control (SPC) in a centralized platform for 30 global sites (and counting), with minimal startup and implementation time. We'll discuss how we use the flexibility of v4.5, and lessons learned as we found better approaches to doing business. The company has since begun a rollout of Camstar Manufacturing, starting in Boulder, CO. As a result, the company is seeing improved product quality, improved process efficiencies, and significant yield improvements.

DexCom, Inc. is the leader in continuous glucose monitoring. The company is rapidly - and gracefully - growing, without breaking its back. This requires process improvements - including reduction of paper, availability and immediacy of information, and scalability of the manufacturing processes.

Implementing Camstar Manufacturing exposed complexities across the entire process. We could see that if we didn't simplify our processes, automation would not help us. In this presentation we will discuss:

• How the modeling process helped operations clarify what they were actually doing
• How we got skeptics on board, and how they became advocates of the paperless process
• Dedicating resources to the configuration of the system to create a robust implementation and reduce costs
• The submission of process change to the FDA, and completing the changes in 30 days
• Benefits such as good quality and high growth while keeping headcount in check, shaving of document review time, and increased capacity
• Ways that the system has helped us handle growth of our manufacturing capacity and facilitate adoption into additional areas
• Future plans for integration with ERP and Quality systems

Get a closer look at the innovations coming in Camstar V5. See a new user experience, productivity tools, intelligence advancements, and rich feature sets available out of the box. All this and more, you won’t want to miss one of these sessions, repeated at two different times for your convenience.

Tessera is a leading manufacturer of lenses for semiconductor and general photonics markets. This presentation will provide a description of the manufacturing and systems that are being implemented on Camstar’s Enterprise Platform to support the shift to high-volume manufacturing using outside contractors.

We will discuss how the system provides:

• Access to real-time data in-house as well as from contract manufactures
• Dynamic prioritization of the shop floor and outside resources
• Visibility for research and development initiatives
• Support for ISO certification
• Metrics on how Tessera is meeting and exceeding our customers’ expectations

Corning Cable Systems (CCS) is a leading manufacturer of end-to-end fiber optic solutions for telecommunications networks. CCS has been using Camstar applications for their manufacturing execution systems since 2001 and has developed an integration approach that provides loosely coupled connectivity to business applications and the shop floor via a messaging layer.

This presentation will provide background on why CCS chose to pursue a loosely coupled integration strategy and provide insight on lessons learned. Included in the presentation will be a detailed discussion of the pros and cons of a loosely coupled (messaging) integration strategy, best practices and lessons learned.