CAPA Projects are typically allocated a vast amount of organizational resources, and are arguably the most time sensitive project a quality department can endure. Yet despite interference from the FDA, many organizations still struggle to close these projects in the allowed timeframe.

How long does it typically take your organization to close out a CAPA project?

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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?

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?