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Medical Device Manufacturer CAPA Benchmarking Survey

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June 2012
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Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, FDAnews survey of devicemakers:

  • Sixty-three percent of companies have increased reporting to senior management in the past two years to improve CAPA performance.
  • Companies using individuals to conduct CAPA investigations — as opposed to teams — are twice as likely to have investigations lingering more than 120 days.
  • Increasing senior-level oversight of complex CAPAs results in a ten percent improvement in closing investigations quickly.
  • Companies using a standard approach to CAPA investigations are twice as likely to report an increasing workload compared to those using a risk-based approach to CAPA.
  • Plus much more…

These findings are part of an FDAnews survey of medical device manufacturers that will take you inside your colleagues’ quality departments to understand how they are approaching the industry’s CAPA headaches.

For the first time ever, FDAnews surveyed 229 medical devicemakers to reveal how the industry is approaching CAPA investigations, what the industry is experiencing in terms of enforcement, and what best practices exist to better manage CAPA investigations.

Buy now to get an unprecedented look inside CAPA programs throughout the industry as well as benchmarks and insights to help you structure your CAPA system for maximum effectiveness and justify your positions with upper management.

In this easy-to-read report, FDAnews pulls back the curtain on CAPA investigations to give you actionable intelligence on questions such as:

  • How and by whom are CAPA investigations initiated?
  • Who is performing investigations?
  • Are companies including deadlines for investigations in their SOPs?
  • What are the requirements for extending a CAPA investigation?
  • What are the greatest problems companies have in maintaining effective CAPA programs?
  • Are budgets for CAPA increasing or decreasing?
  • How do CAPA programs run by regulatory affairs personnel differ from those run by quality officials?
  • What specific techniques improve a company's performance in completing CAPA investigations?
  • What conclusions can be drawn about companies spending more on CAPA investigations?
  • And more.

Complete with 34 tables and analysis, this report will help devicemakers uncover and correct the attitudes and procedures that undermine product quality and leave them vulnerable to recalls, product failures and FDA violations. Discover innovative new techniques for taming CAPA system problems, improving your performance and driving change in your organization.

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