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Harro Hofliger Reduces Risk in Pharmaceutical Manufacturing Equipment with Dyadem
Date:7/30/2008

TORONTO, July 30 /PRNewswire/ -- Dyadem today announced that it has signed a new deal with Harro Hofliger, a Germany-based builder of production equipment for the pharmaceutical industry. Harro Hofliger is using Dyadem's FMEA-Med software to help its customers minimize risk and manage quality effectively during the production of its specialized pharmaceutical equipment.

Harro Hofliger designs and constructs specialized machines for pharmaceutical companies. Among its 400-strong customer base are giants such as Pfizer, Novartis, Astra Zeneca and Johnson & Johnson. The pharmaceutical industry is highly regulated; therefore Hofliger is constantly measuring quality and risk throughout development as well as with customers during delivery. The huge production lines and complex nature of machinery produced makes extensive formal testing of every individual machine function virtually impossible. On average the company conducts 200 projects in a year with as many as 50 or 60 projects running in parallel, requiring diligent quality standards across the organization. Quality is controlled using a risk-based approach, that identifies critical risk factors in the production process and minimizes or eliminates them. Harro Hofliger's focus on quality through the process helps customers rethink the steps that are most critical for the safety of their products while designing new process and production equipment.

To better serve its customers and increase efficiency, Harro Hofliger started using Dyadem's FMEA-Med software, a Failure Mode and Effects Analysis solution that not only ensures consistent product quality, but also drastically reduces the time spent on completing risk analysis studies. FMEA-Med is designed for the medical industry and supports several medical device manufacturing regulations, such as 21 CFR, Part 11. It helps in significantly improving quality and helping prevent patient injuries and costly product recalls.

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SOURCE Dyadem
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