How Merck Life Sciences uses RPA to streamline regulatory compliance

Automated robots assist compliance, thereby helping companies increase revenue and save valuable time, freeing up employees to engage in higher-level tasks.

The pharmaceutical industry is a highly regulated industry, especially for multinational companies that do business around the world.

The regulatory process for pharmaceutical companies involves complex activities related to various value chains - collecting data, applying for appropriate licenses, generating supporting documentation for submissions and supply chain operations - that help order in a timely manner and smoothly pass through the customs of each country in accordance with the regulations involved. A company's trade compliance team not only has to be involved in all of these processes, but also ensures that they are aligned with the ever-increasing number of regulations, which can vary from country to country.

Many pharmaceutical companies still rely on manual/manual processes to support these value chains, although failure to comply with regulations can result in hefty fines. Merck Life Sciences is a leading chemical and pharmaceutical company with 60,000 employees and operations in 66 countries around the world.

Dr. Radhika Mahadev, head of Robotic Process Automation (RPA) at Merck Life Sciences, said, “Relying on human resources is time-consuming and highly error-prone. Automating regulatory processes in the pharmaceutical and biopharmaceutical industries is important to reduce human error. and tedious tasks were critical. To improve efficiency, reduce costs, and speed up time to market while handling various regulatory processes to meet compliance requirements, we ultimately decided to leverage RPA, an increasingly popular method of automating business processes."

Streamlining Supervision Procedures

RPA leverages software robots to capture and interpret the actions involved in completing a given business task, including entering and manipulating data, triggering responses, and communicating with other systems. By simulating these actions previously taken by humans, RPA robots can help enterprises automate business processes, reduce errors and free up manpower to perform higher-level tasks.

As part of its RPA strategy, Merck leverages unattended bots from Automation Anywhere to automate and streamline the creation, management and distribution of its regulatory processes.

Mahadev said, “The project started in 2021. We started in the Asia-Pacific region and then expanded the solution to Latin America and the United States. It took us two years to implement this solution. As of the project As of the end of December 2022, we have achieved coverage in 43 processes and 23 regions, including trade compliance, cross-border logistics and regulatory management."

As part of the deployment of RPA solutions, Merck There is also a cloud-based local development and production control room.

Ankur Kothari, co-founder and chief customer and strategy officer of Automation Anywhere, said, “In the development control room, there are 25 users with different roles. In the production control room, around 150 users are assigned different roles. Because the system is cloud-based, users can open the development/production control room URL in any browser and log in to their user account."

Obtain approval for the automated regulatory process It is a very challenging task for Mahadev. "We are dealing with the most critical and important regulatory process in the value chain that is necessary to obtain marketing approval," she explained. Each flowchart is reviewed by a designated business board member. "

She added, "The IT team developed new SOPs (standard operating procedures) to restrict access to robots on production systems, which is different from access to human users. To allow IT teams to track robot activity at all times, each robot is assigned a unique ID. To date, we have delivered over 130 bots using automation solutions including SAP, Oracle, Web, Windows, Desktop, Office365 Apps, Salesforce, PDF, Email, FTP Server, API, and more. ”

Increase revenue and reduce time occupied with resources

By automating manual processes, Merck saves significant resources and frees up manpower to perform more meaningful tasks.

Mahade said, “Regulatory subject matter experts from 23 geographies can now focus on higher value operations by delegating monotonous chores to RPA. Improved accuracy and compliance through timely submission of regulatory documents. We saved 121,000 man-hours by using it, which allowed us to devote more time to other valuable tasks. ”

Pharmaceutical sales representatives spend a majority of their time tracking the target audience they need to contact and manually inputting their credentials and/or provided content. Rewritten: A significant portion of a pharmaceutical sales representative's time is dedicated to tracking the target audience they need to contact and manually enter their credentials and/or provided content.. They have less time to interact with patients, healthcare practitioners, and administrators.

By leveraging bots, sales representatives can retrieve accurate and timely sales data, manage inventory orders, track customer feedback, and engage in activities that require persuasion and communication skills.

Automated robots can also help manage inventory. They can prevent inventory depletion or overstocking by tracking shipments, automating invoicing, justifying delays, and sending alerts when medicines are approaching expiration dates.

This solution helps improve Merck’s marketing strategy as the business team is able to issue bulk orders in a timely manner. This effectively increases the revenue generated through the business team.

Mahadev said, “Based on commercial forecasts, this will allow us to increase product sales by millions of euros over the next five years, while meeting commercially critical SKU import plans and meeting stock keeping unit replenishment requirements in the long term. This also It will help the supply chain team achieve the goal of delivering products on time."

Mahadev said that Merck is looking forward to the future of cognitive capabilities in the field of automation. Handling unstructured data and decision-making processes is a top priority. Enhanced cognitive capabilities can help shift focus from rule-based automation to processing unstructured data. ”

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