Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Corrective and Preventive Action (CAPA) systems provide a wealth of information regarding the quality of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.
For instance, it is not uncommon for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. (more…)