Posted on Tue, Aug 25, 2009 @ 04:33 PM
Live Customer-exclusive Virtual Event to Share How Industry Leaders are Advancing Product Quality
CHARLOTTE, N.C. (July 30, 2009) - Camstar Systems, Inc. today announced that it will host a virtual customer event for North America on September 17, 2009. The event will feature expert customer speakers from Roche Diagnostics, and a leading manufacturer in solar thin film, among others.
Presenters from these top manufacturers will share insight into:
- Expanding global Manufacturing Execution System deployments
- Diversifying into batch processes
- Opening new plants with all new technology
- Embracing the platform approach to product quality with the expansion of the Camstar platform to Quality Management.
The event will also provide attendees with a "sneak peek" into the upcoming version 4.5 of Camstar's Enterprise Platform for Advancing Product Quality. The new release will include new functionality across its manufacturing execution, quality management, and manufacturing intelligence products. The platform is the first in the industry to truly support Closed-Loop Quality, which is Camstar's model that unifies product and process design, planning, supply, manufacturing, and customer experience.
"The 2009 Virtual Customer Cruise is a great opportunity for our customers across a variety of industries, including Life Sciences, Solar and High Tech manufacturing, to hear first-hand how their peers are using the Camstar platform to advance product quality," said Scott Toney, Camstar's President and CEO. "Executives report that Product Quality is a key strategic objective in driving significant top line growth as well as reducing operational costs and risk. We are very pleased to include Roche and leading solar and high tech customers as part of the agenda, and believe that their knowledge and experience will make this an event to remember for all of our customers."
Registration for the 2009 Camstar Virtual Customer Cruise is open to current Camstar customers at no fee. For more information about the event, please visit http://www.camstarcruise.com/?utm_campaign=PR_camstar.
About Camstar Systems, Inc.
Camstar is a leading innovator of manufacturing software solutions that advance product quality, enabling its customers to deliver the highest quality products on time, the first time, every time. The Camstar Enterprise Platform advances product quality throughout the product lifecycle, from design to planning to supply to manufacturing to customer product experience - all in a closed-loop learning process that allows future products to be designed better and manufacturing processes to be leaner and more efficient.
Camstar is the largest in its market, including enterprise solutions for manufacturing execution systems, process planning, quality management, and manufacturing intelligence. For over 25 years, Camstar has served hundreds of satisfied customers worldwide, including Boston Scientific, Kodak, Carl Zeiss, Life Technologies, Beijing SE Potevio Mobile Communications, ZOLL, CIBA Vision, AMD, BIOTRONIK, Hitachi, IBM and Eagle Test.
For more information, please visit http://www.camstar.com/.
Posted on Tue, Aug 25, 2009 @ 04:17 PM
Total Product Lifecycle Management: Lowering Costs while Increasing Quality"
Accessible at FDAnews.com
Cummaquid, MA, Yardley, PA, Falls Church, VA (June 25, 2009) - Most medical device companies have not progressed very far toward adopting Total Product Lifecycle (TPLC) Management practices. The U.S. Food and Drug Administration is promoting TPLC as a key initiative to speed time-to-market, improve quality and safety, and to lower the cost of medical devices. This was one of the findings of a major study of 212 medical device practitioners released today by the Life Science advisory firm Axendia and research analyst Cambashi, in conjunction with FDAnews.
The full findings of the survey were made public today in a new report entitled, "Total Product Lifecycle Management: Lowering Costs while Increasing Quality." The report can be accessed at www.fdanews.com/total-product-lifecycle-management. The report is the second annual study for the medical device industry, and includes extensive data and recommendations medical device companies can use to reduce costs and improve quality by moving toward a more predictive and concurrent approach to managing the TPLC.
The key findings of the research indicate that despite a total product lifecycle (TPLC) initiative by more than half of respondents, most device companies have not shifted processes and systems to a TPLC approach. TPLC would enable firms to concurrently drive progress and manage all information from the concept and design of a product's lifecycle through commercialization and ongoing safety monitoring. The research found that the majority of medical device firms are still using serial design models, such as stage gate and waterfall.
Moreover, the study found that companies that have adopted TPLC, quality by design, and voice-of-the-customer initiatives are far more likely to have improved their cost of quality and performance to other key metrics than those who have not yet adopted TPLC.
According to the research findings, the majority of medical device companies don't yet use software applications to support their shift to TPLC methodologies. The two exceptions are ERP for business transaction management and EDMS (electronic document management systems) as a vault for regulatory, product, and other documents. Although larger organizations are far more likely to use software than smaller ones, even among those with revenues in excess of $1B, one in four does not currently use QMS (quality management systems), MES (manufacturing execution systems), BI (business intelligence) or PLM (product lifecycle management).
Quality processes are often disjointed, which is understandable without coherent practices and applications to manage the information. For example, ‘operator training' and ‘update standard operating procedures' are the two actions medical device companies most regularly assign to close out a CAPA (corrective and preventative action), yet these actions rarely eliminate the root causes of the problem, which are more likely to be process or product design issues. The study findings show that quality analysis is also difficult. Over 50% of respondents believe that their companies are not able to conduct a thorough review of how raw materials, components or subassemblies, suppliers, product design changes, process changes, CAPA results, or risk profiles impact processes or product quality.
As a result, many medical device companies are not able to eliminate key quality problems and costs. On average, only 20 % of respondents reported a decrease in engineering changes, CAPAs, non-conformances, audit observations and findings, and adverse events, while only 30% reported declining product costs and recalls. In addition, most companies have not seen improvements in time to complete a recall, cost of regulatory action due to poor quality, reportable adverse events, customer reject rate, time to market, or new product introduction times.
The report recommends that companies leverage improved multi-department coordination and collaboration to improve product quality, reduce cost and boost overall business success. For all except the smallest medical device organizations, this will require using appropriate software applications that enhance visibility, data access, analysis and process improvement. Companies can also leverage integrated information systems to attain a single version of the truth, thereby minimizing regulatory burdens.
The research is co-sponsored by major solution providers to the Medical Device industry. These companies and the three research team companies will be distributing the report. Research Sponsors for the study are: enterprise manufacturing and quality software provider, Camstar Systems (http://www.camstar.com/ ); product lifecycle management (PLM) software provider, Dassault Systèmes Enovia (http://www.3ds.com/); Dassault's medical device industry PLM partner Integware, (http://www.integware.com/); management and technology consulting firm, PricewaterhouseCoopers LLP Pharmaceutical and Life Sciences Industry Group (www.pwc.com/pharma); and product lifecycle management (PLM) and quality management systems (WMS) software provider, PTC (http://www.ptc.com/).
About Axendia
Axendia is a leading analyst and strategic advisory firm focused on the Life-Sciences and Healthcare markets. We provide trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia professionals offer a unique combination of deep hands-on industry experience coupled with strategic vision. Axendia serves the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community. Our clients range from startups to Fortune 100. We contribute to our client's success by providing long-range visibility and helping them navigate the ever-changing landscape in the Life-Sciences and Healthcare markets. For more information, visit http://www.axendia.com/ or contact us at info@axendia.com. To stay informed on Industry trends, read Axendia's Life-Science Panorama, a Journal for Industry Executives, at http://lsp.axendia.com/
About Cambashi
Cambashi, based in Cambridge UK and Cummaquid MA USA, provides independent research and analysis of the business reasons to use IT in industry worldwide. It specializes in engineering, enterprise, plant and supply chain applications and the infrastructure to enable industrial firms to use IT effectively. Cambashi publishes market size estimates in the engineering applications Market Observatory and industry issue research studies in the Cambashi Reports Industry Directions series. Cambashi is a member of CATN, an international association of consultants. To learn more, visit: www.cambashi.com
About FDAnews
FDAnews publishes domestic and international regulatory, legislative and business news and information for executives in industries regulated by the U.S. Food and Drug Administration. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books, management reports and conferences to stay in compliance with international standards and FDA's complex and ever-changing regulations to get their products to market faster and boost profits. FDAnews brings you the knowledge you need, when you need it. To learn more, visit: http://www.fdanews.com/
Contacts:
|
Axendia
Daniel R. Matlis
(267) 352-4801
dmatlis@axendia.com |
|
FDAnews
Matt Salt
(703) 538-7600
msalt@fdanews.com |
Cambashi
Julie Fraser
(508) 362-3480
julie.fraser@cambashi.com |
Posted on Tue, Aug 25, 2009 @ 04:09 PM
Chapter 2 in Camstar's eBook Series Features Real Business Results from Top Manufacturers
CHARLOTTE, N.C. (April 30, 2009) - Camstar Systems, Inc. today announced the release of its latest eBook "The Business Case for Advancing Product Quality."
The eBook is Chapter 2 in Camstar's series "Winning Profits in the Age of Continuous Innovation." In Chapter 1 Camstar defined its model for closed-loop quality. Chapter 2 outlines the framework needed to measure advancements in innovation, quality and margin that can be achieved through a closed-loop approach to Advancing Product Quality.
"This eBook is a valuable resource for manufacturers seeking to sustain innovation while ensuring product quality and lowering operational costs," said Karim Lokas, Camstar's Vice President of Product Strategy. "We examined top manufacturers in Life Science, Solar and High Tech industries in various stages of adopting a product-centric, closed-loop quality approach. We found that they have achieved significant improvements in market share and margins while protecting their brands, giving them substantial advantage over their peers that use traditional approaches to quality processes and systems."
The eBook documents results from manufacturers who have:
The eBook is available for download at:
www.camstar.info/ebook_chapter2
About Camstar Systems, Inc.
Camstar is a leading innovator of software solutions that advance product quality in the manufacturing industry, enabling its customers to deliver the highest quality products on time, the first time, every time. The Camstar Enterprise Platform advances product quality throughout the product lifecycle, from design to planning to supply to manufacturing to customer product experience - all in a closed-loop learning process that allows future products to be designed better and manufacturing processes to be leaner and more efficient.
Camstar is the largest in its market, including solutions for manufacturing execution, process planning, enterprise quality management, and manufacturing intelligence. For over 25 years, Camstar has served hundreds of satisfied customers worldwide, including Boston Scientific, Kodak, Carl Zeiss, Life Technologies, Beijing SE Potevio Mobile Communications, ZOLL, CIBA Vision, AMD, BIOTRONIK, Hitachi, IBM and Eagle Test.
For more information, please visit http://www.camstar.com/.
Posted on Tue, Aug 25, 2009 @ 03:59 PM
Compliance-First Approach and Quality Silos are Obstacles to Improving Product Quality
YARDLEY, PA & CHARLOTTE, N.C. (March 19, 2009) - Axendia Inc., a trusted advisor to life science executives and Camstar Systems today announced the availability of findings from a recently completed research study - Quality Management System Trends in Life Sciences.
The research study sponsored by Camstar Systems identified the impact of current Quality Management System (QMS) implementations in the life sciences industry and their effects on product quality, regulatory risk and adverse event exposure across the global enterprise.
Over 125 companies, covering small, mid-size, and Fortune 100 Life-Science organizations participated in the study. They represented the full spectrum of medical device, pharmaceutical, biotech and diagnostic organizations.
"The study revealed that many life science companies are employing reactive approaches to quality, using QMS primarily to manage and document compliance to FDA regulations," commented Daniel R. Matlis, President of Axendia. "This compliance-first philosophy seems to be an obstacle to achieving real, long-lasting quality gains. Quality does not result from simply meeting regulatory requirements. Rather, compliance should be a natural outcome of executing well defined and understood processes," Matlis added.
"Quality programs must ‘close the loop' across all phases of the product life cycle - from design through manufacturing to field use - so the company can deliver the highest quality product, on time, the first time," commented Karim Lokas, VP of Product strategy at Camstar. Manufacturers need to implement a fundamentally different approach to quality management. Rather than piecing together information from multiple and disparate CAPA, nonconformance, adverse event, manufacturing and design systems, the most effective manufacturers implement a closed-loop enterprise platform to create an end-to-end quality process that monitors events from all sources to identify potential problems before a quality issue occurs," added Lokas.
Axendia and Camstar will share in-depth findings, analysis and conclusions from this research study in a series of online executive briefings beginning in mid March. View the briefings at: http://www.camstar.info/QMSbriefings.
About Axendia:
Axendia Inc. is a leading analysis firm focused on the Life-Sciences and Healthcare markets. The firm provides trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia's unique perspective is a result or our focus on the Life-Sciences and Healthcare markets and a unique blend of industry experience and strategic vision. This approach enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia's can be found at http://www.axendia.com/
About Camstar Systems, Inc.
Camstar is a leading innovator of software solutions that advance product quality in the manufacturing industry, enabling its customers to deliver the highest quality products on time, the first time, every time. The Camstar Enterprise Platform advances product quality throughout the product lifecycle, from design to planning to supply to manufacturing to customer product experience - all in a closed-loop learning process that allows future products to be designed better and manufacturing processes to be leaner and more efficient.
Camstar is the largest in its market, including solutions for manufacturing execution, process planning, enterprise quality management, and manufacturing intelligence. For over 20 years, Camstar has served hundreds of satisfied customers worldwide, including Boston Scientific, Kodak, Zeiss, Life Technologies, Beijing SE Potevio Mobile Communications, ZOLL, CIBA Vision, AMD, BIOTRONIK, Hitachi, IBM and Eagle Test.
For more information, please visit http://www.camstar.com/