Quality Training and IT Management: Creating Global Processes and Maintaining Software Excellence for Medical Device Companies

STUDY OVERVIEW

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.


KEY TOPICS

• Executive Summary
• IT Solutions for Quality Activities
• Managing Document Control
• Deploying Quality Training
• Managing Software Quality

• Global structure for CAPA IT system
• Global structure for Complaint Management IT system
• Global structure for Corrections and Removals IT support
• Global structure for Document Controls IT support
• Global structure for Laboratory Data Management IT support
• Annual number of Quality training sessions per Quality FTE
• Percentage of quality training deployed through different channels
• Usage of external vendors for training system
• Centralization of and automation of Compliance/Document Control
• Level of Compliance/Document Control work executed off-shore
• Annual number of objects reviewed by the Quality function
• Number of documents stored in different types of documentation systems
• Percentage of documents changed and reworked over the last year
• Number of change requests evaluated by Software Quality group in the last year
  

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.

METHODOLOGY

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.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.