Chapter 2 in Camstar’s eBook Series Features Real Business Results from Top Manufacturers

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Key Learnings from the Axendia Study and the Future of Product Quality in Life Sciences

May 19, 2009
1:00 pm EDST

A recent research study by Axendia revealed that in the vast majority of Life Science companies, Quality Management Systems were installed as silos with little integration to operational systems. Major results from the study further imply that this siloed approach is a major barrier to managing the containment, enforcement, and disposition of product when adverse event occur, especially across multi-site, global enterprises. One of the more alarming findings from the study reveals that 93% of respondents report recurrences of quality issues after closing a CAPA. In this webinar, understand the implications for the future of product quality approaches in Life Sciences.

Speakers:
Daniel R. Matlis, President, Axendia
Julie Newsome, Director of Quality, Carl Zeiss Meditec
Karim Lokas, VP Product Strategy, Camstar Systems

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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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