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2 Best Practices
Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Consumer Products; Medical Device; Health Care; Orthopaedics
Bausch & Lomb; Boston Scientific; Covidien; Edwards Lifesciences; Ethicon; Medrad; Medtronic; Nitinol Devices & Components; Roche Diagnostics; Terumo Medical; Zimmer
Quality Staffing: Quality function FTEs total about 6 to 7% of total FTEs working in medical devices and related services. For 64% of companies, Quality staff increased by an average of 8% in the past three years.
IT Solutions: An IT solution for CAPA is most common with 82% of benchmark partners indicating that they use one global system in their respective companies. In contrast, Quality Management Review systems remain manual for nearly two-thirds.
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%.
Quality System: Most companies do not maintain a standardized software platform to facilitate risk assessment across products. For nearly 60%, business units take primary responsibility for tracking product risk throughout the lifecycle.