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P102: Process Improvements in Pharmacovigilance Corrective and Preventive Action Management

Poster Presenter

      Heena Murarji

      • Otsuka Pharmaceutical
        United States


To improve the oversight, quality & compliance of PV related records, and reduce the number of findings & CAPAs through effective monitoring. The aim was to develop a governance structure by streamlining the procedures and implementing process improvements (PI) within Global Pharmacovigilance (GPV).


A team was formed to oversee and monitor progress of all GPV records. A gap analysis was performed & the process was streamlined by introducing an integrated approach to manage CAPA activities though utilization of tracking tools and cross-functional collaboration to increase quality and compliance.


Detailed analysis identified gaps in understanding the process and timelines to be followed, appropriate oversight with a common repository for transparency, lack of knowledge in using the electronic Quality Management system (eQMS) and ineffective collaboration across functions. The team identified a need to create a robust process to support the key stakeholders (KSHs) during post audit activities. This resulted in better oversight to ensure timely and effective closure of findings and CAPAs. In addition, new tools & templates were developed like a global tracker, CAPA template, FAQs for using the eQMS. These were stored in a common repository on SharePoint site for easy reference. Monthly metrics were introduced to demonstrate cumulative progress. Implementation of process improvements led to a reduction in number of open CAPAs from 425 in 2015 to 90 by the end of 2017. Further, regular team meetings were scheduled to effectively monitor record status which allowed timely escalation of challenges. The CAPA template was converted into a SMART template which facilitated the creation of robust CAPA plans. The introduction of Kick-off Meetings for the post audit phase with KSHs supported effective and timely management of the responses to findings. A team mailbox was created to streamline all communications through one channel. Standardized email templates were created to effectively communicate & follow up for complete responses. Implementation of monthly status updates shared with concerned KSHs ensured adherence to agreed actions. This greatly helped in reducing the response time, gaining better oversight & compliance. This led to a reduction in the number of open CAPAs to approximately 70 by June 2021. A CAPA Job-Aid was created to document all steps related to CAPA management. Implementation of the above processes resulted in an improved on-time CAPA compliance percentage from <70% in 2017 to 90% in 2021, highlighting tremendous growth & success globally.


CAPA management is a critical activity and non-compliance puts our business at risk, therefore it is essential that the responses and CAPAs are submitted in time and the commitments made are adhered to. The comprehensive and collaborative approach taken for the various process improvements implemented by the CAPA team has enabled GPV to maintain the high level of quality and compliance. Timely monitoring of compliance metrics and communication with internal and external KSH at regular frequencies has increased the oversight and helped to strengthen the collaboration by supporting timely escalations and preventing potential overdue records affecting compliance. The introduction of KOMs with the KSHs to provide guidance during the post audit phase has proven to be advantages by increasing the engagement and improving the quality of the responses and adherence to the timelines. Another integral development was the standardization of communication through a central mailbox and regular follow up activities as reminders, which increased the response rate and allowed CAPA owners to stay on top of their commitments. Moreover, the support provided by the CAPA team with the administrative tasks within the eQMS system has reduced the burden on the CAPA owners and ensured that responses are processed in the system in sufficient time for Global Quality review and approval. Keeping in mind the Kaizen methodology, further enhancements of this process will continue to be evaluated to ensure GPV stays compliant, this will be through extended collaborations with Global Quality and other GPV functions to strive towards an increased CAPA compliance above 90%. The overall process improvements driven by CAPA team have empowered the organization to have increased quality and regulatory compliance globally.