White Paper: Failing To Establish And Maintain CAPA Systems? Your Company Could Be At Risk

The pharmaceutical industry has managed its business in much the same way for decades, focusing most of their resources on the next blockbuster drug. With changes in regulations, declines in drug approvals and a shift towards developing high value biologics, today's manufacturers must begin to shift their focus and address current processes, practices and systems, and take a hard line on improving their overall quality and compliance efforts.

With more than 50 percent of Form 483 observations and warning letters citing Corrective Action/ Preventative Action deficiencies, this paper presents a practical and compliance-focused approach to root cause and corrective actions that will help transform your CAPA efforts into effective, efficient and sustainable quality systems.

With a proper CAPA system in place, companies can focus on their nonconformances that may arise — instead of being overwhelmed by unforeseen issues that may come out of investigations, internal and customer audits, regulatory inspections, QMS reviews, complaints and recalls.