Online Exclusives
March / April 2021

Applying Robotic Process Automation in the Pharma Industry
Edoardo Schiraldi
Applying Robotic Process Automation in the Pharma Industry

Robotic process automation (RPA) software automatically handles manual, repetitive, time-consuming, and highly structured tasks such as data entry and back-office functions. Certain processes specific to the pharmaceutical industry represent strong candidates for RPA implementation, with significant potential savings and the possibility of ensuring compliance.

Robotic process automation uses bots (software programs that work automatically based on predefined configuration and that can interact with systems or users) created within a specific platform to execute one or more processes. The bots can work either together with the user or autonomously and are capable of executing the exact same tasks a user would in their day-to-day activities.1 Thus, RPA is a powerful tool that can help drive a transition from operations centered on “things and people” to approaches primarily using “technology and networks.”2

Robotic process automation can be potentially applied to any process carried out by a company, from very simple tasks—such as generating an automatic response—to very complex activities involving thousands of bots. Common application areas are:

  • Administration, tax, and finance: accounts payable, payment processing, intercompany reconciliation, bank reconciliation, tax reporting
  • Purchasing: expense analysis, expense report management, procurement data management, supplier relationship management, contract management
  • Information technology: security monitoring, help desk management, testing management, application server monitoring
  • Supply chain: forecast and demand planning, data and analytics management, inventory management
  • Human resources: travel and expense management, employees master data management, time record validation

In 2018, global research analysts Fersht and Snowdon3 predicted that from 2016 to 2020, the RPA software market across all industries would grow from $183 million to $1.05 billion, the RPA services market would grow from $429 million to $3.26 billion, the total RPA market (market and services) would grow from $612 million to more than $4.3 billion, and the year-over-year growth would be 20% after an 80% peak.

Robotic process automation Pros and Cons

The main benefits of robotic process automation can be clustered in the following areas:4

  • Better resource management: Robotic process automation allows companies to reallocate employees to value-added activities and processes, thereby increasing productivity and reducing the time workers spend performing repetitive and non-core tasks.
  • Increased throughput: Robots can work continuously with high accuracy and without breaks (24/7 productivity capacity). As a result, the company can produce high-quality products and obtain superior performance.
  • Reduced cost: A single bot is capable of performing multiple processes and usually has low to moderate implementation and maintenance costs. Therefore, investment in RPA solutions may be cost-effective when compared to the labor costs of using workers to perform the same tasks.

However, not all processes can be automated via RPA; therefore, it is not always the right answer for failing processes, operational issues, and headcount challenges. For instance, it’s very difficult to apply RPA solutions to unstructured processes in which users make decisions that are not based on predefined rules and logic. Furthermore, to calculate the RPA net benefit, it’s important to recognize that users would need to spend time providing inputs (triggers and data) after RPA implementation.

In a 2008 study,5 590 industry leaders from a variety of industries were surveyed about their organizations’ use of intelligent automation, including RPA. The study found that 5% of respondents are unsure about the use of RPA, 20% had no plans to use RPA, 34% had pilot RPA programs, 27% were moving to production, and 13% had scaled-up, industrialized RPA systems.

Robotic process automation in the Pharma Industry

In the pharmaceutical sector, RPA solutions can help organizations control costs in different processes, meet compliance requirements, and deliver new drugs to market with safety, efficacy, and profitability. For example, RPA solutions can improve regulatory compliance because bots do not deviate from programmed steps and audit trail history is tracked.6 Furthermore, the scalability of RPA technology could ensure the automation of employee’s more routine daily tasks guaranteeing at the same time a high level of accuracy and compliance.7

In these ways, robotic process automation may prevent significant market delays. Also, qualified employees could potentially be reassigned to value-added activities that are key to industry success, such as core research and development.8

Validation is one of the key challenges that must be addressed before robotic process automation can be widely adopted by pharmaceutical companies. In a regulated environment, any system that performs a decision-making function should be validated, and a solid change control process should be put in place. RPA systems seem to have the potential to effectively meet these requirements because they are configurable, auditable, and specifically designed to not “color outside the lines.”7

The main ways that robotic process automation can help pharma companies comply with process validation quality guidelines and GxP regulations may be summarized as follows:9

  • Using bots to follow a specific standard operating procedure (SOP) in the same manner as a qualified human operator
  • Providing comprehensive, unchangeable, and time-stamped activity logs
  • Reducing business risks and errors through the automatic execution of repetitive and routine manual activities
  • Reporting errors and exceptions raised during the process execution

Use Cases

The following are examples of use cases of robotic process automation implementation in the pharma industry.

Electronic Batch Record Review

Bots can be used to perform batch record review activities, ensuring that all the documentation needed is actually included and that information collected from different systems involved in the process is coherent and within operational parameters. When reviews performed with robotic process automation detect no anomalies, the reviews can autonomously be closed and logged by the bot. However, if the bot detects any inconsistency or discrepancy that requires human evaluation, the robotic process automation solution can be programmed to report the issue to one or more users before proceeding with the next steps of the process.

Pharmacovigilance

Given the huge amount of adverse event data that companies must periodically process, pharmacovigilance is one of the main areas that could benefit from robotic process automation. Currently, companies tend to manually manage case reports because the data vary in quality, structure, and format and are not easily integrated. Robotic process automation could be the answer to this problem, allowing companies to process an increased caseload while maintaining the current cost base.8

Furthermore, robotic process automation has the potential to aid marketing authorization holders (MAHs) in active searches of databases such as the EMA’s EudraVigilance database, which tracks individual case study reports (ICSRs) of suspected drug side effects.10 . A robotic process automation bot can access the EudraVigilance database and download ICSRs on a daily basis; then, the bot can automatically analyze all the ICSRs based on predefined rules to decide if a case is related to the MAH’s products and/or to active ingredients used in the MAH’s products.

Trial Master Files

The trial master file (TMF, or eTMF if the master file is in an electronic format) is a master data repository used by sponsors to record and integrate all the activities related to a clinical trial. Typically, data entry and document upload are manually performed, and when a trial involves multiple contract research organizations, their eTMFs may not be integrated. One RPA solution uses bots to load and index documents within the eTMF, which can substantially reduce data processing time.8 Solutions integrating RPA and optical character recognition (OCR) technology could improve reliability and mitigate risk by eliminating errors and improving accuracy in the eTMF; increase scalability with instant ramp-up to account for demand surges, and support GxP compliance with an internal controls framework.

Regulatory Submissions

In the regulatory submission process, RPA solutions can speed up certain required activities, such as document status tracking and creating a records dossier, thereby shortening the process timeline and the time to market.8 Steps to bring value with RPA include mapping the document landscape to understand compliance requirements, walking through the as-is process to identify pain points and areas for improved user experience, developing a new automated workflow enabled by RPA, and proving the technology can manage the new workflow with better compliance at a reduced cost.

Financial Record-Keeping and Reporting

RPA solutions can help streamline data workflows, data verification, and scheduling during account reconciliation and reporting of transaction data, eliminating the manual scheduling of jobs in the backend, ensuring GxP compliance, and making it easier to manage tax and legal activities. If the process and the final report submission are completely automated, the time needed for the reconciliation of transaction data may be reduced from days to hours, while accuracy is improved.

Accurate financial record-keeping during drug trials is critical to maximize tax deductions and minimize tax penalties. RPA solutions that automate R&D drug trial work orders and invoice extraction can help companies avoid discrepancies between taxable and nontaxable invoices. This automation can allow the company with R&D departments located in different countries with different taxation rules to efficiently manage taxation issues.

Conclusion

In the highly regulated pharmaceutical sector, RPA solutions can enable organizations to comply with regulatory guidelines while taking full advantage of automation and innovation. Furthermore, RPA can decrease labor costs, reduce the time spent by employees on repetitive and noncore tasks, and reallocate users to higher value-added activities. In a nutshell, adopting RPA helps pharma companies bring safe and effective drugs to market in a shorter time and at a lower cost.

Facilities & Equipment
Adv Manuf
Manufacturing Operations
Pharma 4.0™

About the Author

Edoardo Schiraldi
Corporate Program Manager
Menarini
Edoardo Schiraldi has a master’s degree in economics and management. After earning this degree, he joined Accenture as a consultant involved in national and international...