REGULATORY AFFAIRS

One Regulatory Intelligence

The Challenges of Managing and Tracking Regulatory Requirements Around the Globe

Working in today’s global environment can be extremely challenging for Regulatory teams who are supporting products being developed, registered and commercialized around the world. This dynamic environment requires an awareness and understanding of constantly evolving legislation and requirements that are occurring at local and global levels.

As new requirements emerge, R&D teams must be aware of the requirements, recognize the impact of a change, and be able to develop compliance-based best practices.

Affiliate Challenges

Traditionally, affiliate teams track and manage this information in spreadsheets and SharePoint lists, creating local and regional silos of information. Spreadsheets are updated manually, so real-time access to current information is delayed.

Affiliate teams conduct the entire spreadsheet-driven process using minimal technology:

Manually monitor health authority announcements and publications
Review and assess applicability of changes and interpret their impact
Integrate new requirements into best practices in R&D, manufacturing, and commercialization processes

This common approach impedes an organization-wide understanding of requirements and often leads to duplication of efforts. The manual maintenance is error prone and can lead to increased compliance risks.

NNITs Regulatory Intelligence Solution

The NNIT Regulatory Intelligence Solution automates global monitoring while offering a single source of truth for global Regulatory requirements. It is based on two technological pillars: Artificial Intelligence and the Microsoft Power Platform. Artificial intelligence monitors and captures new and/or updated regulations. The Power Platform is the single source of truth for collected data. It offers helpful workflows integrated into Microsoft applications (Microsoft Teams) so teams can share high-quality data across the organization.

Our “prototype as a foundation” approach starts with foundational technology and configurable workflows and provides the required architecture to develop a robust and relevant database of requirements. Customer specific requirements are addressed within a rapid application development environment. Core functionality can be augmented with organizational experiences and lessons learned.

Our solution leverages the Microsoft Power Platform to create:

An interactive solution with robust workflows and notifications
Version control and audit history that support 21 CFR Part 11 Compliance
Dashboards and visualizations that enable search and compare activities.
Possibility to add own interpretation and experience to health authority requirements

By using the Microsoft Power Platform, clients with existing Microsoft partnerships gain added value.

Capture, Curate and Access

NNIT’s Regulatory Intelligence Solution uses artificial intelligence (AI) to monitor and extract data while still supporting manual data entry. This “push” model flips the script and delivers relevant updates to teams in real time enabling them to capture, curate, and access important requirements more efficiently.

NNIT Expertise Behind the Solution

The NNIT team includes Power Platform Developers, Regulatory Affairs Consultants, Migration Specialists, and AI Data Scientists who collaborate with clients throughout the implementation to deliver the right Regulatory Intelligence solution for their individual needs. Our agile implementation methodology enables us to deliver the first release in three months. The NNIT Application Services team ensures continued success with ongoing maintenance and support.