Automation’s role in supporting regulatory operations

Published: 10-Aug-2022

Robotic process automation (RPA) offers a cost-effective solution to laborious and repetitive document and data processing

Process automation has been on the agenda of regulatory operations and affairs professionals for some years because the potential for RPA-enabled transformation of workload management is substantial.

The required volumes of administrative throughput are high in this field and pharmaceutical companies are, or certainly should be, evaluating any conceivable solution that expedites data sharing and synthesis processes.

RPA’s core use case is to reduce the time taken to perform repetitive tasks — freeing up staff to use their knowledge and skills more productively while reliably processing repetitive tasks that are prone to human error.

Here, Lakshmeenarayana G. Goundalkar (pictured), Vice President of Regulatory Services at Celegence, outlines key use cases for the adoption of automation in post-market surveillance (PMS) document lifecycle management for medical devices (MD) and in vitro diagnostics (IVD).

What is RPA?

Robotic process automation (RPA) is a software-based technology that utilises “bots” to replicate human activities and perform a typically manual process, such as copying and pasting data entries between formats. In medical writing, these are process-driven tools that are explicitly programmed to assist with document content generation and data reuse.

Automation’s role in supporting regulatory operations

For example, there will be certain sections within documents wherein the content has been copied from a source manuscript, such as a product brochure that has a standard text, template and formatting. An RPA bot can perform this activity and create draft content for use in other paperwork — provided that the source and target are standardised.

Document lifecycle management for medical devices and in vitro diagnostics

The writing and maintenance of regulatory documents needed for MDR and IVDR compliance has traditionally created large redundancies in content collation and use.

Post-market surveillance (PMS) documentation requires constant maintenance that, without an automated tool, would mean regular revisions. The challenge broadly falls into four categories:

  • repeating data within multiple reports
  • changing the master data in the Technical File leads to sequential updates in all related reports; manual tracking methods to identify, update and verify these changes are error-prone
  • updating repeated data within the same report
  • scheduling: regulatory documents go through a specific lifecycle in terms of maintenance and related submissions to the authorities.

From source administration to document lifecycle management and verification, writers often tell the same story and repeat low-value work over and over again. New data is continuously added from multiple sources and, while messaging may pivot or get more refined, much of the source data is repeated throughout the documents.

Streamlining their adoption into critical documents such as Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCP) reports, Post-Market-Surveillance Reports (PMSRs) and Post-Market Clinical Follow-Ups (PMCFs) is an imperative for many regulatory professionals.

RPAs can also support scheduling activities. They can be programmed to understand when a document is due to be updated or submitted and, subsequently, perform work and resource allocation for respective roles in the medical writing process and then initiate those projects.

It’s important to note that effective RPA technologies will not reduce the need for quality human medical writers. They will, however, change their desired skill set and allow them to focus more on understanding and articulating data to create a cohesive scientific narrative.

New regulations: IVDR 746/2017

The EU’s new IVDR came into force on 26 May 2022. The regulation drastically changed the way IVD medical devices are regulated by augmenting previous, and adding new, requirements.

Most notably here, it introduced Post Market Performance Follow-Ups (PMPFs) as a completely new concept that brings the regulation more in line with the EU MDR — in which the established PMCF is its equivalent. Both PMCF and PMPF are now mandatory requirements for manufacturers launching products in the European Union.

Automation’s role in supporting regulatory operations

The PMPF stipulates that the performance of devices is continuously monitored throughout their lifecycle. This system is now an essential element of PMS that, once launched in the market, proactively and reactively gathers a device’s usage experiences.

A PMPF process must continuously collect all data related to the performance of a device in the post-market phase, identify emergent risks and maintain the acceptability of the benefit-risk ratio.

This continuous review has created a new regulatory consideration for IVDR manufacturers; as above, changes to master data and subsequent updates in all related reports can be cumbersome and error-prone when performed manually.


The best approach to introduce RPA into the medical writing function is to identify where tasks are executed according to well-understood, harmonised and defined requirements … but remain resource-draining or inefficient. It is in this sweet spot where most scope exists to advance the work with digital tools.

Automation that accelerates the generation and harmonisation of data throughout multiple documents and reduces errors related to manual data entry allows medical writers and other authors to focus on higher-value tasks.

This not only improves the efficiency and quality of medical writing, but also allows regulatory affairs teams to quickly understand project status throughout the entire process.

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