Device companies must have the right software in place to prevent issues with quality.

“A lot of quality solutions come from the old mentality that quality equals compliance. The fact is, that’s not true anymore,” said Karim Lokas, vice president of product strategy and marketing for Charlotte, N.C.-based Camstar Inc., a supplier of software that advances product quality. “You can meet the letter of the regulations but not produce a top-quality product. Software that is geared to compliance does not cut it anymore. It has got to be geared to producing a safe and effective product. You can’t get great quality by focusing on compliance, but you can satisfy compliance requirements as a byproduct of focusing on quality.”

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MES Extends its Reach  - For better results, manufacturing software is being integrated with other common business programs.

By William Leventon

Medical device makers require even more software assistance than that provided by manufacturing execution systems (MES), which manage and monitor factory production work. Other commonly used programs help manufacturers with tasks such as quality management, business planning, and product development.

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Lowering the Cost of Quality for IVD Manufacturers  - Breakthrough processes enabled by new technologies can reduce quality costs.

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Software Systems Breaking Boundaries for Device Makers  - Software for medical device operations tends to be divided into well-established, compartmentalized categories. But some firms recently have been trying to break the mold by introducing systems that stretch across two or more of these categories.

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Camstar Thriving where Few Tech Firms Dare to Go  - Why would the software company move its headquarters from the technology-rich Bay Area to come here, an area where tech companies have little history and make up a small part of the region's economy? Yet today, under new leadership, Camstar seems to be thriving in its new home.

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Turning Wishes Into Commands  - Want to Improve Yields? Reduce the Risk of Recalls? Software Makes It Possible.

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Sophisticated software systems provide an essential compliance tool for a regulated industry operating in a global economy

Camstar Systems Inc. (Charlotte, NC, USA) offers an MES (manufacturing execution system) and quality system combination. The firm’s Medical Device Suite is geared to manufacturing compliance and quality. "Our software helps in both aspects," says Rajkumar Raqupathi, life sciences solutions consultant. "But we go beyond and also cover enforcement of good manufacturing processes (GMP). We have the complete solution for modeling, manufacturing, and quality directives," he says.

"It is an enterprise-like system," says Susan Lamb, senior manager of product marketing. "We have [designed] it so that multiple sites can log into it for a single solution, and we have installed some on a single plant level. It is very flexible," she adds.

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Selecting and Using a Manufacturing Execution System - An effective manufacturing execution system can help drive quality and productivity improvements.

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 Special Report: Healing Time - Medical products sector attacks regulatory, performance issues with rich systems mix.

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Leveraging technology for IVDs: Lessons from other sectors - Karim Lokas describes ways that In Vitro Diagnostics manufacturers can learn to align technology with compliance and business initiatives and put manufacturing processes in overdrive.

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