After analyzing the customer’s business processes and requirements, we conceptualized a dossier due
diligence automation solution based on Enate and UiPath. Enate would serve as a business process management
(BPM) solution, facilitating project and case workflow management, task assignment, and analytics and
reporting. Integrated with Enate via API, UiPath bots would execute dossier due diligence and automate
additional tasks, including dossier data exchange across corporate systems. The high flexibility of both
platforms allowed the solution to be tailored to the customer’s specific business needs and scale over time
with new workflows and RPA bots.
Our team set up Enate to manage the medicine registration flow and orchestrate tasks between employees and
RPA bots. We also configured UiPath robots and leveraged GenAI capabilities to validate dossier structure
and content against predefined rules as well as collect medicine data from product trackers and
automatically distribute it to relevant stakeholders via email.
Before the full-scale deployment, we released a pilot version that automated the entire due diligence
process for one region with a limited number of compliance checks and business notification process
management. This approach helped us ensure stakeholder alignment, reduce the risk of rework, and establish
effective communication processes. During the pilot stage, the team finalized functional requirements and
formalized dossier due diligence business rules as well as configured bot- and ML-based compliance checks
and set up integrations with other corporate systems, laying the foundation for the platform’s
scalability.
During full-scale implementation, we configured the necessary rules to assess the compliance of all
modules within a dossier, incorporating around 500 regulatory rules. We also automated due diligence and
notifications across other company branches, configuring Enate workflows to meet the regulatory
requirements of 50+ countries.
After the deployment, we conducted a series of stakeholder workshops to demonstrate the system's
functionality and onboard users to the new automated workflows, while addressing questions as they arose.
Functionality
Dossier due diligence
Comprehensive checks of the required document availability and content within each dossier are performed
by the UiPath bot in combination with Generative AI. UiPath bots, built according to the customer’s
business rules, can be run at any stage of the submission process. Thanks to the system configurations,
country- or dossier-specific rules can be easily modified or added, which facilitates the expenditure of
the solution’s automation capabilities.
The actual tasks for the bot to run automated checks are enabled with the help of Enate, with three main
processes involving registration (initial registration of a medicine), variation (post-registration
changes), and renewal (re-registration after the initial registration expires).
RPA enhancement through Gen AI & ML
To support due diligence involving complex decision-making and processing heterogeneous, unstructured
data, we enhanced RPA-based compliance checks with Generative AI. We combined a UIPath-powered automation
solution with Large Language Models (LLMs) to enable context-aware data analysis and intelligent
automation.
We opted for the GPT model to work alongside UiPath bots, allowing them to process various document
templates and extract, analyze, and structure document data. By interpreting document context, the GPT
model eliminates the need for strict bot rules and enables prompt-driven dossier due diligence. The
interaction between the GPT model and UiPath bots occurs via API calls.
First, the UiPath bot segments customer documents, including scans and non-editable PDFs, into logically
consistent sections to ensure accurate contextual interpretation of each section during processing, even
for very large files. Then, the bot sends specific document sections to the GPT model together with
prompts and automatically captures, structures, and records the responses. After that, consolidated
compliance check results, including detailed findings and required follow-up actions, become available in
Enate for review and management.
For complex content analysis, such as molecular formulas’ structure checks, we developed a custom
Python-based ML model triggered by the UiPath bot.
Business notifications automation
A UiPath bot automates the preparation and distribution of regulatory notifications by gathering data from
multiple systems, compiling it into the required format, attaching supporting documents, and sending
notifications to stakeholders. This helped reduce processing time from around 30 minutes to 1-2 minutes,
while still allowing human intervention if information is missing or requires adjustment.
Additional functionality
Task management
Enate supports end-to-end task management, including project and project template creation, task
assignment between employees and RPA bots, and progress tracking.
We also customized the Enate solution’s interface, developing custom UI components to support verification
process validation, case-specific data visualization, and dynamic field control.
User enablement & security
Enate enables role-based access control, allowing multiple users to collaborate on the same dossier while
ensuring secure user authentication and permission management.
Reporting & analytics
Managers, scientists, and other stakeholders can monitor the dossier due diligence process via Enate
dashboards. To address the customer’s specific reporting needs, we extended Enate with custom fields to
track additional metrics, including error rates, error occurrence times, automation process duration, and
verification success rates. While Enate provides broader analytics and reporting capabilities, UiPath bots
generate detailed due diligence check reports.
