Repeat Corrective and Preventive Action (CAPA) investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action or preventive action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3. What’s going wrong? Why is this happening to so many of us?

Have you used VAK in design or delivery of your quality training? What was your experience? Did it make a difference?

According to an announcement issued this month, the FDA may now issue a Warning Letter “close-out letter” once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. The FDA may issue a close-out letter when, based on evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

This is a great incentive for manufacturers to quickly address and remediate their warning letter findings.

CAPA is a critical quality subsystem that, when executed correctly, can provide an organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. Yet many organizations struggle with CAPA, from ongoing and repeat investigations to lack of management control.

A CAPA System itself must be compliant, effective and efficient. But how do we get there? What elements do you consider to be essential to creating a sound CAPA System?