Life sciences companies have many regulatory responsibilities,
including the obligation to document and maintain consumer feedback on the safety and efficacy of their products. A major firm saw that obligation increasing exponentially, with the volume of Individual Case Safety Reports (ICSR) doubling year over year.
The company asked Cognizant to examine its largely manual
process and design an automated solution. We saw an
opportunity to introduce RPA, which is proving to be extremely
effective in environments that rely on manual rule-based
processes. Essentially, RPA allows automation to take over
manual tasks, enabling people to shift their attention to
higher value
A life sciences company needs to automate a highly manual process that had become a regulatory and quality risk for the firm. We built an RPA solution that addressed the immediate issues. Realizing the power of the process, it will be leveraged in other parts of the organization.
In developing the RPA solution, we saw it as a first step to introducing automation that can be utilized in other areas of the organization. We started with an important but relatively transfer of data, known as E2B transmissions. Our team designed and implemented bots that automate the sorting and data-entry stages of the E2B transmission.
The solution delivers numerous benefits, including faster processing with greater consistency and fewer errors. More important, its modular design can be customized and scaled for future needs for other types of documents and transmission modes.
A forward-thinking solution
The immediate goal of the project was to replace and automate repetitive manual activities with a zero touch RPA solution for the processing of ICSRs submitted by consumers and monitored by pharmaceutical industry regulators.
The longer term goal, however, was more far-reaching and required careful planning. First, we had to ensure that the solution would stand up to regulatory scrutiny. If and when regulators wanted to inspect the reports, the company had to be able to make them available immediately in the form the
regulators required.
Second, we needed to ensure that it was scalable, so we could expand process automation to other areas of the organization. To ensure inspection readiness, we adopted a rigorous approach, testing, documenting and validating bots in three phases comprising over 300 test cases. Building a scalable solution meant a modular approach that can be customized as needed. The modular approach also enables faster deployment, so the company can respond rapidly to change in the always-evolving life sciences industry.
The RPA solution was completed and went live in just seven months. New automation efforts are in development to incorporate areas where more complex processing is needed, along with certain cognitive elements such as artificial intelligence and machine learning.
© 2025 Copyright with Jain Consulting Grup LLC
