Harro Hofliger Reduces Risk In Pharmaceutical Manufacturing Equipment With Dyadem

Dyadem recently 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.

"Quality was always top priority and FMEA-Med makes it easier to meet our standards. Our customers also like the risk management service that we offer," said Jan Schikora, Head of Quality Assurance & Validation, Harro Hofliger. "Although our quality levels have remained constant, now the process of maintaining the standard is far less painful for us internally."

Before investing in Dyadem's FMEA-Med software, Harro Hofliger used standard spreadsheets for its risk analysis and reporting, requiring hours of hand-coding and formatting, thereby slowing the analysis process considerably. The cost and time savings were the biggest benefits accrued by Harro Hofliger using Dyadem's FMEA-Med. The time engineers spent on documentation decreased from one week to one day, for each of its projects.

"We run multiple risk assessments for multiple customers on any given day. Each customer uses different notations and rating systems for the evaluation of critical processes, so flexibility of the software was a key issue," Schikora said. "Dyadem was the only vendor that offered the flexibility that we required upfront. All of Dyadem's competitors charge expensive consulting and servicing fees for providing comparable flexibility."

"Maintaining quality and minimizing production errors is especially crucial in the pharmaceutical industry given that a production error could mean the difference between life and death," said Kevin North, president and CEO of Dyadem. "While minimizing risk is always difficult, doing so within resource constraints can be even more challenging. Our goal with FMEA-Med was to create a software solution that automates quality analysis for better compliance and better transparency and seeing Harro Hofliger's results validates our strategy."

About Dyadem
Founded in 1993, Dyadem is the market leader in Quality Lifecycle Management and Risk Lifecycle Management solutions. Dyadem provides software and services that empower companies to manage quality, mitigate risks, achieve regulatory compliance, plan for business continuity and improve profitability. Dyadem works with 85% of the Fortune 500 companies and serves the high tech & electronics, medical devices, oil and gas, chemical, automotive, pharmaceutical and aerospace and defense industries. For more information, visit www.dyadem.com

SOURCE: Dyadem