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Did You Know?

Did you know that a centralized event management approach to CAPA control can help medical device companies comply more effectively with the FDA and simultaneously allow for horizontal reporting between issues and events (e.g., deviations, customer complaints, nonconformances)?

Many medical device companies currently funnel their issues and events via a channeled process. In other words, customer complaints are reported and channeled to CAPA (if necessary) and then subsequently reported on. These complaints for example often cannot be compared to deviations since deviations are reported via another channel.

A channelized system isn't necessarily a bad system. In fact it works well for some companies but for medical device companies that need to centralize all of their issues and events and report on those issues and events horizontally, a centralized system is highly recommended.


MasterControl offers both centralized and channel QMS CAPA solutions as well as CAPA training. To learn more about our new event management "command central" system feel free to contact a MasterControl representative.

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