CAPA Programs - Corrective Action Preventive Action Programs

Automating Corrective Action Preventive Action (CAPA) Programs in FDA and ISO Compliance Environments

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.

Simplifying CAPA: Seven Steps
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