AI
Turn AI Ambition into Compliant, High ROI Reality
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.
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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.
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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.
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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.
AI Use Cases
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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.
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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.
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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.
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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.
Insights
Life Sciences, Data, Regulatory Affairs, Smart supply-chain
The NDC-12 Cross-Industry Pilot: Key Findings & Insights From Phase 0
Life Sciences, AI, Data
From Hype to Reality: Architectural, Strategic, and Data Lessons for AI in Pharma
Life Sciences, Private, Public, AI
Agentic AI vs. AI Agents: Why This Distinction Matters Across Regulated Industries
Life Sciences, AI, Quality
AI in Quality: How Specialized Assistants can Transform Quality Processes
Life Sciences, Clinical, Data, Digital Manufacturing, Drug Safety, Regulatory Affairs, Smart supply-chain
How to build a universal translator for pharma data with FHIR
Life Sciences, Private, Public, AI
Agentic AI in Action for Regulated Industries
Life Sciences, AI, Clinical, Data, Drug Safety, Regulatory Affairs
Three priorities that will shape Life Sciences R&D through 2026
Life Sciences, AI, Data, Veeva Solutions
Webinar: Stay Ahead of Veeva Releases - How AI can Streamline your Risk Impact Assessments
Life Sciences, Private, Public, AI
Trusted AI: Turning Compliance into a Competitive Advantage
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.
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Veeva
Enabling more intelligent Life Sciences workflows with integrated AI assistants like FRED, directly inside the Veeva environment.
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Microsoft Azure
Providing scalable, secure, and compliant cloud infrastructure for AI deployments - fully aligned with EU AI Act and GxP compliance needs.
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Databricks
Powering advanced data engineering and AI model development pipelines for complex and heterogeneous life science datasets.
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Snowflake
Delivering flexible and compliant data storage and analytics solutions, enabling secure sharing and faster insight generation across regulated data landscapes.