Automating corrective and preventive actions in FDA environments

There are numerous reasons to implement a corrective and preventive action (CAPA) program. Two of the most obvious are regulatory requirements and improved product quality. Initially, according to this white paper by MasterControl Inc., companies will create a paper-based system primarily due to the low start-up costs and flexibility that such a system provides. Next, they move to a paper and electronic hybrid system; then, they either create a custom application that is completely electronic or purchase a third-party software application.

An important element of an effective CAPA system is the tool used to control the process. Having a tool that distributes the tasks to the appropriate people not only streamlines the process, but also promotes greater buy-in and accountability on the part of employees. To gain the full advantages of an electronic system, an organization should look for a solution that can connect all of their quality data and is flexible enough to be configured to match a company’s forms and processes.

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