New CAPA System

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Case Study

New CAPA System

QualityHub assisted a major international pharma and medical device company in reengineering their corporate-wide CAPA system. The work involved numerous GAP analyses and working with an internal team to redesign the new CAPA system. Extensive training was performed which included “train-the-trainer” to ensure that 40,000 employees worldwide could understand and use the new CAPA system.

To determine if the program was successful, we performed an additional gap analysis of their CAPAs across all regions and business segments of the company for two years, following deployment of the new CAPA system. These gap analyses showed great improvements over time.

Note: When FDA later inspected the company, they told the company they had one of the best CAPA systems FDA had seen.