RPA is revolutionizing Life Sciences by automating repetitive tasks and freeing up time for your teams to focus on more value-adding and strategic activities.

Robotic Process Automation, or RPA as it is often called, has made significant strides in the IT and service sectors outside of Life Sciences. The concept involves technology referred to as “robots,” which are essentially software programs designed to replace human interaction with computer interfaces and between systems. You can think of it as a simpler yet more dynamic form of integration solution among different systems, processes, and technical solutions.

The robot can log into systems, have a user profile, and with it, for instance, read emails, read documents, analyze texts, sort data, and act based on pre-defined workflows. By using RPA, manual processes can be replaced so that only the cases that deviate from the set criteria for each workflow need to be handled manually. For example, large data sets, repetitive tasks, or very precise analyses and executions are good indicators of where robots can be useful. An installation usually involves one or more robots working in parallel, managed via a common software. The robots can work actively around the clock, producing reports, compiling data, and replacing human execution.

In Life Sciences, RPA can play an important role in driving innovation and efficiency while achieving quality improvements.

RPA can significantly increase efficiency in pharmaceutical manufacturing, MedTech operations, or clinical studies. The real limitation lies in the application of automation. Any process that can benefit from automation—preferably well-defined, repetitive, and data-driven processes—can profit from RPA solutions. This can range from raw material handling to quality control and regulatory compliance. RPA helps boost efficiency and streamline production processes.

Management organizations for computerized systems can effectively use RPA in several areas, such as support management, where error messages and system logs can be quickly and efficiently analyzed. This allows the support organization to be informed via an email about the issue and suggest corrective actions. Periodic reviews are another example where RPA proves useful, for instance, by quickly analyzing users and permissions in a system, comparing them against HR systems, and then generating a report. It can also automatically deactivate users and remove permissions for staff who have left or changed roles.

It is important to define the right processes when choosing to implement RPA. Fundamental parameters that can be used to evaluate suitability typically include repeatability, defined workflows, data volumes, and accuracy, as well as the amount of manual work that can be replaced. The evaluation should be based on the purpose of the automation. Is it to save money, time, or improve quality? Depending on this, the value of the implementation varies and requires different evaluation criteria.

As often with technology, it may seem straightforward at first glance. Indeed, it can be, but it’s crucial to consider issues of manageability and administration so that the solution implemented over time becomes an effective and contributing complement to the processes within which the robots operate. Adopt a governance mindset during implementation to avoid introducing simple solutions that will require significant maintenance to sustain. Solutions should be modular and parameterized. Frameworks for management and implementation standards greatly facilitate long-term manageability.

Furthermore, what sets RPA apart in Life Sciences are the regulatory expectations. Will the robots operate within GxP environments? Do the processes require validation? For instance, does the solution need qualification according to established procedures originating from medical device regulations like 21CFRp820, ISO13485, if they operate within critical processes? These types of questions can make implementation more complex but are entirely manageable.

Regarding IT compliance issues, there needs to be a review and decision-making process regarding the data that robots can work with and access. For example, a robot may handle sensitive data, both regulatory as Electronic Records and sensitive from a privacy perspective. One question might be: who is responsible for changes to data that are entirely automated, and how does one ensure data integrity when processes are automated?

RPA is a critical component for innovation and efficiency in pharmaceutical manufacturing. With tools like UiPath, MicroFocus RPA, and Power Automate, companies can achieve significant improvements in their manufacturing processes, leading to higher quality, increased security, and reduced production costs.