No quality process is perfect. In regulated environments, this assumption is addressed by requiring a corrective action and preventive action (CAPA) process that will control the impact of deviations and nonconformances and make sure that the problem does not recur. This requirement is a major driving factor when regulated companies look for a CAPA solution.
Some companies have a formal CAPA process, but others that don't typically incorporate CAPA in their quality assurance and quality control processes. Regardless of the structure of the CAPA process, regulated companies almost always need CAPA solutions to make sure they are compliant.
For companies under the jurisdiction of regulatory agencies such as the FDA, EMA, MHRA, MHLW, or those that adhere to ISO, ICH, EU Annex 11 and other international quality standards, any action (or result of an action) that does not meet specified requirements is considered a nonconformance. When a nonconformance occurs, it must be controlled. But depending on its severity, it may not require a CAPA. When a nonconformance does require a corrective action, it may not necessarily call for a preventive action. But serious nonconformances are likely to require both. It is, therefore, important to distinguish nonconformance solutions from CAPA solutions.
For regulated companies, the key is to remember that a corrective action deals with finding the root cause, and effective corrective action solutions must address the cause of nonconformance.
On the other hand, a preventive action, as its name suggests, tries to prevent the problem by determining its likelihood of occurring again and reducing the probability of its recurrence. This essential difference between corrective action and preventive action requires appropriate CAPA solutions that provide appropriate tools.
MasterControl CAPA solutions are designed to comply with the most stringent regulations anywhere. MasterControl automates and streamlines not only the CAPA process but also nonconformance and other quality processes critical to effective CAPA implementation. MasterControl corrective action solutions provide the following:
MasterControl corrective action solutions offer other benefits beyond CAPA management that will help improve your overall compliance efforts, including:
Corrective Action Preventive Action processes are central to any GxP system. MasterControl's CAPA program ensures the corrective action system improves product quality and safety, increases customer satisfaction, and ensures FDA compliance. To learn more about our corrective action program contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.
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