Current Regulatory Tools And Processes

Regulatory professionals are generally confident in their organization’s overall strategy when it comes to compliance.

But they note that certain processes like finding documents and completing product registrations are particularly error-prone, while others, like preparing assessments and certifications, or responding to customer requests, are time-consuming and could use more automation.

Overall, professionals feel confident in their company’s regulatory strategies and processes.

Nearly 9 in 10 feel assured that their company’s regulatory strategy is the right one (87%) and that they have adequate visibility into the regulatory & compliance work occurring at their organization (87%).

Additionally, 82% maintain that they can easily track and manage their regulatory and specialist work to make sure efforts are successful.

9 in 10

Regulatory Professionals Feel Confident that
Their Company's Regulatory Strategy is the Right One

Professionals' Confidence in their Company's Regulatory Strategies and Processes

Dealing with customers and doing paperwork are major time-hogs that regulatory professionals would love to see automated.

Regulatory professionals indicate that customer requests are a time-consuming area of their day (34%), followed by finding documents in internal systems (33%) and preparing assessments and certifications (33%).

It’s no wonder these are also the areas where they would like to see greater automation: Nearly 2 in 5 (38%) assert that automating assessment preparation would lead to the greatest efficiency gains followed by finding documents internally (34%), responding to customer requests (33%), and providing feedback to R&D and Innovation teams (33%).

Regulatory requirements and documents are not easy to track and manage.

Regulatory professionals admit they have the greatest difficulty managing product regulations and certifications (49%), overseeing regulatory requirements by country (45%) and legalizing documents (44%).

Regulatory Processes Causing the Greatest Challenges for Professionals

Businesses are using a mix of software solutions to manage their daily regulatory processes. However, this mix does not meet their current and projected business needs as 39% recognized the increased need for digital transformation related to regulatory affairs.

Regulatory professionals have a wide range of responsibilities – from dossier management to responding to customer requests to collaboration with R&D and Innovation teams. To get it all done, they rely on a siloed assortment of legacy tools, from shared Excel sheets to custom-built software.

Standard enterprise tools like the Microsoft Office Suite and Google Docs are the most widely-used (94%). A major concern of some professionals is the lack of uniformity of the tools used by regulatory stakeholders.

I would like it if our software was completely uniform with everyone else’s.

- VP, Chemical, Virginia, USA

Tools Used For Regulatory Compliance Processes

Standard enterprise tools remain the most commonly used by regulatory teams for basic documentation.

About half of regulatory professionals use standard enterprise tools (like MS Office, Google Docs) for processes like document creation (55%), finding documents in internal systems (50%), and requesting documents internally and externally (48%).

This is in line with the findings from the past Regulatory Trends studies which found that spreadsheets, email, shared folders and standalone documents were the top 4 tools.

94%

Of Regulatory Professionals Use Standard Enterprise Tools for their Compliance Work

Businesses also rely on third-party cloud-based software tools and custom in-house software tools for a variety of functions.

Third-party tools are most frequently used for providing feedback to R&D and Innovation teams (45%), completing product registrations and dossier management (41%), and preparing assessments and certifications (40%).

Bespoke software is most commonly used for handling customer-requests (44%) and providing feedback to R&D teams (41%). Additionally, 38% of professionals use it for preparing assessments and certifications, 34% for dossier management.

This is on par with the past study results, when nearly one-third of respondents said they used custom-built software for dossier preparation and product registration.