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merzkrashed replied to the topic Make sure to cover pitfalls in the forum Project Management Process and Medical Device Development 7 years, 9 months ago
Adding to the discussion, another pitfall in Gantt chart that if you have poorly defined CAPA time-frames.
CAPA which means establishing a corrective and preventive action system, which is required in (QSR) a quality system regulation for medical device for marketing products in the united states.
Solution: So, you must clearly define how long each phase of your CAPA will take, provide appropriate rationale for activities that will take a long time to implement, and explain what you plan to do if you go beyond the specified time-frame. It is important to have defined time-frame criteria for CAPA resolution as part of your CAPA procedures.