Biopharmaceutical companies still trying to find the best ways to measure effectiveness of CAPA processes

A well-defined CAPA system is essential for any biopharmaceutical company to drive quality improvements across the organization. Hence, it is imperative for biopharmaceutical organizations to measure the effectiveness of their CAPA processes to identify potential areas of improvement in their quality function.

According to recent research by Best Practices, LLC, companies are still trying to find the best ways to measure the effectiveness of their CAPA processes. This can be extremely challenging, as there is no "one size fits all" approach, due to the difference in products and processes amongst companies. Currently more than half of benchmark participants use number of recurrences and number of repeats to measure the effectiveness of CAPA processes.

The related report, "Benchmarking BioPharma Quality and CAPA Processes," provides leaders with critical benchmarks on CAPA processes and quality resource management. Pharma & Medical Device executives can utilize this study to build a strong CAPA system and thereby develop a robust quality function, within tight budgets.

Key research objectives included:

• Assessing CAPA Processes
• Uncovering Benchmarks For CAPAs, NCEs, FDA Questions, Inspections And Observations
• Defining CAPA Effectiveness Metrics
• Measuring The True Cost Of Quality
• Highlighting Strategies To Manage Quality Costs And Align Spend Mix

This benchmarking research drew participation from 14 executives from leading biopharmaceutical organizations. Data is charted throughout the report for the "Total Benchmark Class" as well as for the "Large Company Segment", which includes 9 companies.