Beyond the hype: what is RPA’s role in Regulatory Affairs?

Demanding, high-volume document and data processing-based tasks make Regulatory operations administratively labour-intensive, so interest in robotic process automation is understandable. But where is the technology’s ideal application, and how can life sciences firms extract maximum benefits? Amplexor’s Agnes Cwienczek offers a reality check.

The potential for transforming workload management in Regulatory operations using robotic process automation (RPA) is considerable, due to the intensity of administration involved in the function. RPA technology offers to free up expensive talent to use their knowledge and skills more productively, while reliably processing routine work items that can result in human error as the brain switches off.

For simple, structured task execution, strong target use cases include the sorts of task once routinely outsourced to third-party service providers to optimise cost-efficiency. These might include automated data entry; extracting data from Excel sheets for uploading into databases, importing documents, or archiving them; checking data or document quality; or parsing emails, for instance.

In Clinical regulatory operations, meanwhile, where there are hundreds of hefty reports coming in from contract research organisations (CROs), an RPA tool could help take the strain from teams who otherwise would have to input data manually from these documents. Creating or verifying hyperlinks between related data in documents is something else RPA tools promise to help with.

Checking documents for submission-readiness according to defined criteria is another strong candidate for RPA.

Add intelligence to task automation, and the scope for process transformation and efficiency improvements grows further still. Intelligent, AI-enhanced RPA can cope with more complex, unstructured scenarios. Take the task of processing and parsing emails. Here, RPA could transform the extraction of standard data from routine documents such as standard agency approval letters. . Agency approval letters can vary by country, but an RPA tool with some degree of machine intelligence could help by first determining which country the letter has come from, and therefore where to look to extract the required information and how to interpret it before uploading the results into a regulatory system.

Delivering quick wins as part of bigger transformation initiatives

Over time, companies are becoming more mature in their application of the technology as well as more ambitious in their aims, having experimented with the technology and glimpsed the potential benefits. Targeted RPA applications help to highlight what’s possible, inspiring investigation into more advanced use cases – and reassuring teams that automation isn’t a threat to their jobs, but rather the key to making them more interesting.

The use of RPA as an agile, interim solution to deliver quick wins in parallel to larger-scale transformations of regulatory information management (RIM) is becoming increasingly common, for example. Where companies are impatient to deliver ROI and accelerate speed to market now, targeted RPA applications – turned around quickly and affordably - can readily demonstrate their worth and reaffirm the business case for Regulatory digitalisation.

Building a good, solid regulatory intelligence database is a good example of a next-generation RPA use case. A blended approach of RPA-extracted data and human insights can result in a powerful resource with wide-reaching benefits in accelerating and improving the quality and success rates of global submissions.

Challenges & opportunities

Identifying strong, targeted use cases will be important, as companies become more serious about RPA. This will help to build credibility and confidence around the technology, and break down fears about technology taking people’s work.

Validation of RPA technology could conceivably be a challenge, particularly where systems are continuing to evolve using AI and machine learning. Niche, application-specific ‘bots’ which execute repetitive tasks and are relatively restricted in their use and predictable in their performance, however, should not pose too much of a problem.

Additional decisions include to what extent companies develop and run their own RPA capabilities, or lean on third parties to create and operate the tools for them. There is an expectation that some process automation tools will remove the need to rely so heavily on external services to improve operational cost-efficiency. In other cases, use of advanced technology will increasingly become a pre-requisite when choosing service providers, to ensure maximum economic benefits from outsourcing.

To fully exploit RPA’s potential, companies should be thinking about further standardising the way they capture, record and manage data. RPA bots are relatively easy to code; the bigger challenge is harmonising processes and channels and shoring up data quality so that automation can be applied easily and reliably.

The biggest wins will come by identifying where Regulatory’s main pain points are - where tasks are executed according to check lists, or which are the most resource-draining or inefficient outsourcing relationships - and use this as the steer for advancing with digitalisation. Processing product data from contract manufacturers (CMOs) and compiling and publishing dossiers are likely to be strong candidates, for instance. The important thing is to think laterally when assessing the options.

About the author

Agnes Cwienczek is Head of Product Management & Consulting at Amplexor, a prominent digital solution provider specialising in global compliance, digital experience and content solutions designed to transform process efficiency, increase revenue generation, reduce time to market, and ensure the highest standards of quality.

www.amplexor.com

agnes.cwienczek@amplexor.com