Recent reports show that 88 percent of FDA warning letters have been issued due to the failure of the CAPA program that a company has implemented. Corrective action software can help companies avoid the failure of a corrective action program.
Corrective Action Preventive Action programs are especially designed to maximize efforts dedicated to the investigation and correction of quality issues in order to prevent recurrence. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a sound corrective action program improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.
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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.