A client was struggling with on-time batch release, missed CAPA closure deadlines, and a CAPA program that was difficult to manage due to the large volume of deviations and CAPAs being created. CAPA completion delays prevented the client from reaching organizational and financial goals, and the product was not released on time, which impacted their customer relationships and potentially impacted product availability.
Due to the experience and expertise of CAI, team members knew that they could help the client not only understand their issues but also provide methods to resolve the issues. Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process. CAI’s knowledge of quality management systems, deviations/investigations, the CAPA process, life science manufacturing, and human performance proved to be an asset.