With a prestigious legacy spanning over three centuries, global pharmaceutical giant Merck embarked on a remarkable journey four years ago. Daring to break away from traditional practices, the organization embraced cutting-edge technology in robotic process automation (RPA) and AI bots to streamline its regulatory filing processes. The result? Enhanced efficiency and drastic reductions in documentation time.
Overcoming internal obstacles
Embracing newer technology was met with internal resistance. Still, the India and Asia-Pacific teams at Merck demonstrated the power of bots by successfully implementing them in a project for Korea. What previously took six to eight months to complete in time-consuming documentation work can now be done within a month. Meanwhile, the North American team experienced a significant boost in productivity, with the conversion of 6,000 purchase requisitions into purchase orders streamlined by 97% and the turnaround time reduced by 60%. Delivery time for external vendors also improved, increasing from 83% to 93%.
Dr. Radhika Mahadev, head of RPA at Merck Life Science, highlighted the initial challenges faced within the organization, where resistance was encountered while attempting to introduce bots for order entry. The scientific team, unfamiliar with order-entry or customer-facing roles, needed a compelling use case to be convinced of the technology’s potential.
Revolutionizing regulatory paper submissions
Central to Merck’s operations is the crucial task of submitting papers to regulatory bodies for product approvals. Before any product, whether it be a medical device, drug, or service, can be launched in a country, it must undergo rigorous regulatory processes and review by subject matter experts. The documentation requirements for such submissions are extensive and time-consuming.
Two types of paper submissions are involved: healthcare submissions destined for regulatory bodies like the U.S. FDA and EMA and license submissions presented to a country’s regulatory boards for trade compliance.
As the need to address the voluminous paperwork emerged, Dr. Mahadev and her team sought innovative solutions to streamline the process and reduce the burden of compliance-related documentation. Automation and RPA emerged as viable options, potentially revolutionizing the status quo.
Streamlining order entry
Merck receives orders from global customers through various communication channels and formats, such as email, fax, PDF, and postal mail. The process of converting customer purchase requisitions into purchase orders following specific formats, as prescribed by country regulators, was managed by an order entry team.
The team decided to implement bots for the Korea leniency regulatory program as their initial use case. This program is critical in checking country regulatory compliance for toxic and non-toxic products. Failure to file the required product paperwork with the country council before launching in Korea could result in substantial fines or canceled licenses.
The project presented several challenges, especially in Korea, where building language capabilities in Bengaluru within six to nine months was a nail-biting experience. Bots had never been used for regulatory work before, making the entire venture met with skepticism.
However, the successful clearance of the entire backlog of paperwork for approximately 30,000 products within a month using AI-powered bots from UiPath and Automation Anywhere silenced the doubters, leading to broader acceptance within the organization.
Expanding RPA’s Influence
Buoyed by the success in Korea, Merck expanded the use of RPA to tackle the Japan Industrial Safety and Health Law (ISHL) inventory program. The volume of paperwork for a large portfolio of products made this an ideal second-use case for bots.
After achieving success in two countries, Merck integrated the technology at the order screening level, a pivotal step in the decision-making process for product launches in different countries. Human subject matter experts continue to play a crucial role in validating 98% of regulatory compliance, while 2% is reserved for expert manual review, serving as a safeguard mechanism.
Global adoption of bots
Merck’s successful implementation paved the way for bots to assist with regulatory filings across 23 geographies worldwide. Additionally, bots are now deployed in supply chain operations and customer care, further enhancing operational efficiency.
With their transformative journey far from over, Merck envisions utilizing bots for AI projects and integrating RPA with analytics. The organization also aims to leverage disruptive technologies to tackle the challenges of unstructured data, which constitutes nearly 60% of its activities.
Merck’s success story showcases the immense potential of AI bots and RPA in revolutionizing critical processes within the pharmaceutical industry. By embracing innovation and automation, Merck continues to drive efficiency, accuracy, and effectiveness in the complex landscape of regulatory compliance and beyond.
