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Best Practice Database
Quality, Compliance and Regulatory » Assuring Quality Programs
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In order to achieve higher efficiency, Medical Device and Technology companies are increasing their investment levels in both the tools that provide IT solutions and in the training of their employees within the Quality function. Both of these areas are an integral part of ensuring that products continually meet a certain level of quality standards and regulations.
Best Practices, LLC conducted this benchmarking study to assist medical device companies in their approach to both their IT solutions and training their employees. In addition, the research provides valuable insights into the centralization and automation of document control and the document storage model and levels within the Quality function. The study also includes different approaches companies are taking in order to mange software quality staffing and reporting.
Medical device leaders can use this study to evaluate the support they provide via training as well as their management of software quality and document control.
Deploying Quality Training: On average, 36 training sessions were performed per Quality FTE last year. Reviewing documents accounted for more than half of the training, followed by classroom training at 26% and e-learning at 18%.
Managing Software Quality: At nearly 30% of companies, the software quality group is a dedicated resource. Per billion dollars in revenue, software quality groups evaluated more than 750 change requests last year on average. More than half, or 58%, off shore some aspects of software quality management.
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eleven executives from 11 medical device companies. Five executives participated in interviews.