The Customer
The customer is one of the leading multinational pharma companies headquartered in France. They are the world's fifth largest seller of pharmaceutical drugs in the prescription market. They are the biggest producer of vaccines and they also focus to establish themselves in the consumer health sector. The client is working toward affordable access and quality care to ensure underserved populations receive the treatments they need.
Challenges
Complexities and delays in completing the late ICSR investigations on time
Missing information and data discrepancies were rampant due to the use of static MS Word form
The existing process of communicating via email using MS Word to obtain RCA and CAPA was cumbersome and time-consuming
Manual steps had to be performed to evaluate the performance of the stakeholders
The Solution
Indegene deployed a web-based SharePoint application and electronic lateness documentation form (e-LDF). The platform is used to communicate and obtain the RCA and CAPA from the deviation owners. We established robust workflows integrated for late ICSR assignments for compliance managers to investigate, provision to add required queries inside the e-LDF form, and automated reminders and alert messages to compliance managers and deviation owners. The provision for automated escalation management for the delay in responses from deviation owners was also implemented.
Outcomes
Indegene enabled identification of accurate root causes to obtain relevant CAPA with improved speed and process efficiency
We ensured timely availability of data for monthly/quarterly compliance reports for the client to perform appropriate trend analysis and simplify oversight of stakeholder performance
100%
Adherence to timelines
32%
Increase in speed and first pass accuracy
45%
Reduction in manual efforts