By MasterControl
Published in: MasterControl e-mail
Published on: February 20, 2025
For companies whose products are subject to regulatory requirements, especially those under the jurisdiction of agencies like the U.S. Food and Drug Administration (FDA), a corrective action/preventive action (CAPA) process is needed to address and mitigate the impact of quality events such as deviations and nonconformances. Many companies, however, are not equipped to implement an effective CAPA process. It may be that their employees lack the proper training and background to perform corrective actions. Or perhaps they don’t have access to tools and strategies that adequately support a formal CAPA process. A review of the FDA warning letters issued each year indicates that some companies only think about CAPA after the fact – when quality issues have already emerged, and they have no choice but to address them. Most organizations have some sort of CAPA system in place, but too many are woefully inadequate. This brief provides an in-depth look at each critical phase of CAPA and provides a blueprint to help life sciences companies successfully manage them.
