Pioneering Robotic Process Automation in Life Sciences

Life sciences companies carry heavy regulatory responsibilities, including the obligation to document and maintain consumer feedback on the safety and efficacy of their products. One major firm saw that obligation growing exponentially, with the volume of Individual Case Safety Reports (ICSRs) doubling year over year.

The company asked Category Tech to examine its largely manual process and design an automated solution. We saw an opportunity to introduce robotic process automation (RPA), which is proving extremely effective in environments built around manual, rule-based processes — automation takes over the repetitive tasks, freeing people to focus on higher-value work.

At a Glance

A life sciences company needed 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, and having seen the power of the approach, the company now plans to leverage it across other parts of the organization.

The Outcome

• Reduced end-to-end cycle time by an average of 30%.
• Improved first-time accuracy from 85% to 99%.
• Improved regulatory compliance from 95.7% to 96.12%.
• Improved turnaround time compliance from 88.6% to 91.9%.

RPA Improves Efficiency, Consistency, and Quality

In developing the RPA solution, we saw it as a first step toward introducing automation that could be used across other areas of the organization. We started with an important but relatively contained transfer of data known as E2B transmissions. Our team designed and implemented bots that automate the sorting and data-entry stages of that transmission process.

The solution delivers faster processing with greater consistency and fewer errors. More importantly, its modular design can be customized and scaled for future needs — across other document types and transmission modes.

A Forward-Thinking Solution

The immediate goal of the project was to replace and automate repetitive manual activity with a zero-touch RPA solution for processing ICSRs submitted by consumers and monitored by pharmaceutical industry regulators.

The longer-term goal, however, was more far-reaching and required careful planning. First, the solution had to stand up to regulatory scrutiny — if and when regulators wanted to inspect the reports, the company needed to make them available immediately, in the exact form regulators required.

Second, the solution needed to be scalable, so process automation could expand into other areas of the organization. To ensure inspection readiness, we adopted a rigorous approach: testing, documenting, and validating bots across three phases comprising more than 300 test cases. Building a scalable solution meant a modular architecture that could be customized as needed — which also enables faster deployment, so the company can respond quickly 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 already in development to incorporate areas requiring more complex processing, along with cognitive elements such as artificial intelligence and machine learning.

This case study reflects results reported by the client at the time of publication. Individual outcomes may vary based on organizational scope, existing systems, and implementation approach.