Earlier this year the FDA released statistics that should alarm the entire medical device industry. Since 2009, it appears that more than 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 over 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: a project management platform with collaboration, risk management and QMS features that stores, tracks and enforces procedures and work they contain.
All while capturing collaboration content to turn it into meeting agendas, minutes, and reports to create both as standard operational documentation and evidence of regulatory compliance.