Earlier this year the FDA released statistics that should alarm the entire medical device industry. Since 2009, it appears that one-third of all FDA inspections resulted in voluntary or official actions. See the black line in the chart below. The percentage has been stuck between 30% and 40% for over a decade.
Why hasn't this percentage gone down over the years? It should be closer to zero by now. Either QMS software vendors don't recognize the problem or can't or won't see a solution beyond what they already offer now.
The solution is software. But, not more of that same QMS software. And, certainly not more outsourcing.
The solution to the FDA Compliance Crisis is 21st Century collaboration software with QMS features.