People walking through a modern office environment, representing collaboration in an AI-driven enterprise workplace.
Mental Health A line styled icon from Orion Icon Library.

AI

Turn AI Ambition into Compliant, High ROI Reality

Picture of a beautiful forest with a data stream running up a tree, representing the evolution of AI.

A governed approach to Artificial Intelligence in regulated environments

Artificial intelligence is increasingly embedded in daily work, but many organizations adopt it through disconnected tools, individual experiments, or generic copilots. This results in inconsistent outcomes, unclear ownership, and limited insight into how AI is used across processes and teams.

In regulated industries, these limitations prevent AI from becoming a dependable part of core operations. When decision paths, data sources, and responsibilities are not transparent, AI usage remains confined to non‑critical tasks and isolated use cases.

Powering Compliant AI in Regulated Industries

Our AI platform and products are built to work seamlessly within regulated industries, so you can accelerate insight and automation while staying fully compliant with the EU AI Act, GxP, and other industry standards.

  • Alera – Validated AI Platform for Regulated Industries

    What is it:

    Alera is NNIT’s validated AI platform for systematic, repeatable AI use in regulated environments.

    Alera features role-based AI agents, curated knowledge, and full transparency, enabling teams to work with accountable AI in a secure chat interface and automate regulated tasks.

    Why It Matters:

    • Validated AI that scales: Regulated industries need reliable AI tools that function across multiple workflows. Standard AI copilots are not up to this task.

    • Built for governance and auditability: Designed for validation, observability, and traceability so AI can be trusted in critical processes.

    • Secure and cloud-agnostic: Deploy in your preferred environment, integrate with regulated systems, and get your own customized version.

    Example Use Cases:

    • Enable hybrid teamwork with specialized AI-agents working alongside human consultants in defined roles (PM, validation, development, testing).

    • Harmonize global master documents with local regulatory or market-specific versions to ensure that local adaptations remain consistent with approved content.

    • Orchestrate chains of agents for contained tasks like comparing data, finding discrepancies, suggesting resolutions, translating, and escalating to humans when needed.

    • Analyze drug databases, patient records, and literature to detect potential drug–drug interactions and adverse effects.

    Read more here

  • Lumina - AI Delivery Framework for Modernizing Regulated Applications

    What is it:

    Lumina is NNIT’s AI-enabled delivery method for legacy transformation and application modernization in regulated environments.

    It brings requirements, decisions, code, tests and documentation into a shared, version-controlled context and coordinates specialized AI agents under clear governance and human approval.

    Why It Matters:

    • Faster modernization with less risk: Accelerates requirements-to-code and automates test and validation, while keeping changes traceable, controlled and fully documented.

    • Shine a light on existing code: Lumina can analyze existing code and documentation, identify gaps and produce updated, reliable documentation that adheres to approved standards.

    • AI model agnostic: Lumina is not locked into a single AI technology or vendor. It supports full data and infrastructure sovereignty. 

    Example Use Cases:

    • Modernizing legacy public-sector or regulated applications by creating reliable insight into existing code and documentation.

    • Translating requirements into structured development tasks with consistent context for teams and AI agents.

    • Keeping documentation and test foundations continuously updated as requirements change.

    • Establishing a repeatable, governed way to apply AI across the Secure Development Lifecycle (analysis, build, test, documentation) for DevSecOps-ready delivery.

    Read more here

  • FRED - Your Veeva AI Assistant - Context-Aware Intelligence Inside Your Veeva Platform

    What It Is:

    FRED is NNIT’s AI assistant designed specifically for Veeva users in Life Sciences. FRED brings smart search, automated summarisation, and proactive assistance directly into your day-to-day workflows.

    Why It Matters:

    • Work Inside Veeva: No jumping between systems — everything happens in your familiar environment.

    • Better Productivity: Spend less time searching for information and more time making impactful decisions.

    • Customised to You: Fine-tuned for your company’s processes, policies, and compliance requirements.

    Example Use Cases:

    • Instantly locating approved content and regulatory submissions in large Veeva libraries.

    • Auto-generating summaries for approval workflows.

    • Suggesting next best actions in clinical or quality project tasks.

    Read more here

AI Use Cases

  • Contract handling – Public Sector

    Solution

    AI solution designed for public authorities that helps identify old contracts for use in new contract negotiations, which are then developed in a chatbot.

    Functionality

    Optimizes and automates the review of several hundred contracts with external vendors quickly and accurately – while maintaining the security and formality of the material.

  • Patient Safety – AI Advise

    Solution

    The AI solution supports healthcare professionals with advice for patients to optimize proper medication use and patient safety.

    Functionality

    Based on built-in AI functionalities, relevant information concerning precautions, side effects, or special considerations is summarized – based on age and gender.

  • SOP Document Harmonization

    Solution

    AI processes Standard Operating Procedure (SOP) documents, collecting and categorizing them based on similarities.

    Functionality

    Helps build and improve data for AI use by auto-identifying outdated or duplicate documents and highlighting discrepancies or risks.

  • MBR – Migration tool

    Solution

    Large-scale migration project from one MES production system to a newer version.

    Functionality

    AI automates the process of identifying and converting handwritten comments from old Master Batch Record (MBR) PDF documents to newly updated versions.

Wherever you are on your AI journey - we’ll get you to compliant, production-ready, and delivering ROI.

Our Strategic Partnerships

At NNIT, we believe that delivering business ready, compliant AI solutions for regulated industries requires strong partnerships with the world’s leading technology providers. Our ecosystem accelerates innovation, ensures interoperability, and keeps you ahead of regulatory change.

  • Veeva

    Enabling more intelligent Life Sciences workflows with integrated AI assistants like FRED, directly inside the Veeva environment.

  • Microsoft Azure

    Providing scalable, secure, and compliant cloud infrastructure for AI deployments - fully aligned with EU AI Act and GxP compliance needs.

  • Databricks

    Powering advanced data engineering and AI model development pipelines for complex and heterogeneous life science datasets.

  • Snowflake

    Delivering flexible and compliant data storage and analytics solutions, enabling secure sharing and faster insight generation across regulated data landscapes.

Talk to our AI Experts

Let’s scope your roadmap, de risk your compliance, and unlock rapid ROI from AI

When you submit your inquiry to NNIT via the contact form, NNIT process the collected personal data in accordance with the Privacy Notice, where you can read more about your rights and how NNIT process your personal data.