Did You Know?
Did you know that for blood and biologics companies CAPA management processes and solutions can become the Achilles' heel of the overall QMS system?
Take for instance a company that has a workable CAPA management solution but is not gathering and recording all the initial issues and events that according to the FDA need to be gathered and reported.
Generally "this glitch" occurs because the CAPA system is not connected to an issue/event (e.g., complaints, deviations, out-of-specification results or key events) input system and/or because there is no system that ensures that all issues and events are recorded when received.
Blood and biologics companies need to consider automated systems that streamline all issue and event inputs and that provide the automated prompts and intelligence necessary to ensure that the riskiest inputs are quickly escalated to the CAPA system while the less risky issues and events are contained and resolved within a closed-loop system outside of CAPA to help prevent "Death by CAPA."
MasterControl provides the QMS CAPA technology that makes CAPA management the engine of the QMS vehicle. To learn more about MasterControl's QMS CAPA system and related CAPA training courses, please feel free to contact a MasterControl representative