Compliments of Compliance-Alliance
The pressure on regulatory compliance is increasing business risks and putting pressure on costs and performance. Corrective Action Preventive Action (CAPA) management is integral to process control efforts conducted by medical device organizations to adhere to FDA and cGMP regulations. The consequences of CAPA non-compliance are costly and significant, resulting in damaged brand reputation and, potentially, a company's long-term profitability. Effective CAPA management is more than just a regulatory requirement. A good business practice can reduce company liability and warranty claims and increase customer satisfaction.
The purpose of this survey on Achieving and Maintaining CAPA Compliance was to find out about the practices firms are using in their corrective and preventive action systems.
More than 370 professionals in medical device firms completed the survey. Respondents represented firms of various sizes and class of devices.