The FMEA-Med (failure mode and effects analysis) system is a “plug and play” package that is designed to help pharmaceutical manufacturers comply with the industry production standards and harmonize risk definitions and measurement.
A Dyadem spokesperson explained that such an approach is necessary because the “pharmaceutical and medical devices industries are highly regulated and all of the regulatory bodies not only mandate risk management, but describe [it] as a top management function.”
He added that: “Use of FMEAs help flag high risks that are over a particular threshold value and, more importantly, allows top management to have visibility into those top risks and hence make the governance of risk possible.”
Dyadem’s spokesman also commented that the platform’s knowledge management, analysis and customized US Food and Drug Administration/CE/ISO-compliant reporting modules can improve the sharing of data during all stages of the manufacturing development process.
He explained that Harro has obtained the system under a perpetual licensing agreement that entitles “any employee within the company to access the FMEA-Med solution, within a defined concurrent user limit.” Dyadem is also providing application support and upgrade service at no extra cost.
“We provided two sessions of online training, one basic and one advanced, to Harro Hofliger to maximize their return on investment. Additionally, Hofliger has worked with Dyadem professional services and support teams to get FMEA-Med implemented at Harro Hofliger including configuring their corporate templates based on their standard operating procedures.”
At present the FMEA-Med system is used by numerous major healthcare and pharmaceutical firms, including: Johnson & Johnson, Abbott, Eli Lilly, Genzyme, Genentech, Amgen, Roche, Wyeth, and Bristol-Myers Squibb.
A Hofliger spokesperson told in-PharmaTechnologist.com that the FMEA system is being used to develop ”capsule filling and weighing machines, patch production lines, wallet packaging lines and all kinds of prototypes for pharmaceutical products not yet on the market.” He added that “Since risk assessment is a living process during our projects, our customers get a valuable input on where the critical steps in the process are. With this understanding, our customers can train their employees and create the necessary SOPs [standard operating procedures].”