Punya Abbhi, COO at Celegence, explains how the adoption of digital technologies enables companies to manage their regulatory compliance requirements in a more efficient and reliable manner.
Key insights:
- The ability to automate the copy and pasting of data entries for regulatory information management allows for the more efficient creation of content and data reuse.
- To best harness digital technologies’ capabilities, companies can identify where tasks are executed according to clear, harmonised, and defined requirements.
- RPA is software that seeks to mimic human abilities, allowing medical writers to focus on the work of articulating data to create a convincing scientific narrative.
Compliance at pharmaceutical companies is often perceived solely as an enabling function – it needs to be executed to required standards but can be a burdensome task with little opportunity to create additional value.
Compliance does need specialised expertise, collaboration between departments within an organisation and, traditionally, several well-established manual processes. This means that compliance programs may only ever be as powerful as the skills and number of people involved.
This is where digital technologies can make it possible to keep up with the growing amount of data. Organisations must explore how to optimise data collection, remediation, syncing, and submission to external authorities to streamline compliance efforts.
Leveraging robotic process automation technology
RPA is software that seeks to mimic human capabilities to increase efficiency and reliability in certain, well-defined, and repeatable tasks.
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There is a significant opportunity to use RPA across the healthcare industry, with the potential to employ the software in managing electronic records and data sharing, appointment scheduling, data analytics and diagnostics, and in regulatory operations, among others. The ability to automate the copy and pasting of data entries for regulatory information management for instance, allows for the more efficient creation of content and data reuse. As the software is automated, it can perform these tasks faster, more consistently, and for longer periods of time when compared to humans.
A Pegasystems survey of decision-makers employing RPA solutions found that 63% stated it was a ‘major component’ of their overall digital transformation.
Streamlining the process
To best harness digital technologies’ capabilities, companies can identify where tasks are executed according to clear, harmonised, and defined requirements. RPA can provide a solution and offer a better alternative when these tasks are resource-draining or inefficient.
For example, RPA can be used in management of data in RIMS (Regulatory Information Management Systems) that may require data elements to be verified against documents before being entered into the system. These data elements might even need to be added in more than one screen in the system, and verification that the correct data was submitted to the system can be time consuming. By utilising bots for this type of work, regulatory associates are free to focus on QC activities and process improvements.
RPA technology can also support scheduling activities by programming the software to understand when a document is due to be updated or submitted. At this point, it can assign the work and resource allocation to the correct individuals and initiate those projects.
A supplement, not a replacement
It is important to point out that RPA software cannot replace human medical writers, nor will it decrease the demand for their work. Instead, it allows medical writers to focus on the work of understanding and articulating data to create a convincing scientific narrative.
There are also limits to what the software can help with. RPA is limited by its programming – if it does not have the correct instruction to identify and copy certain data, no action will be taken.
However, in specific use cases, the automation enabled by RPA can accelerate the generation and harmonisation of data across multiple documents. Just as importantly, the software can reduce human input errors on manual data entry tasks. This improves the overall efficiency and quality of medical writing, whilst also providing regulatory affairs team updates of project status throughout the entire process.