A new approach to QMS and CAPA management isn't necessarily a revolutionized approach from the one your company already employs. Ken Peterson, CAPA expert and founder of Pathwise, Inc., states that "Making a few well-timed changes to build more intelligence into your process by having key questions prompt you from data point to data point can make it easier for those doing the work, as well as for those who need to see the logic."
New views on issue/event management include 1) keeping your options open in regard to the system you will implement and 2) getting the appropriate CAPA training. System types can include a centralized event management solution, a channel management solution and a basic CAPA management solution. The centralized event management solution is something new for most companies and can be very revolutionary as long as the employees who utilize it know what they're doing. Peterson emphasizes this point on a regular basis: "Allowing all inputs to enter into one command central Event Management system allows for better controls, reports, and searching. You can pull data across non-typical lines and fields. For example, I recently searched for a problem in an animal lab on "twisted intestine" and got an autopsy report, complaint file [plus] several deviations and could compare them to one another."
To learn more about your QMS CAPA system options, please contact a MasterControl representative.