IBM Consulting Regulate-AI

The case for change in Regulatory Reporting

The Challenges | Hurdles in Regulatory Reporting and Compliance: Manual Drafting of Complex Reports Highly skilled staff spend excessive time authoring lengthy and repetitive regulatory documents, resulting in high labor costs and long submission timelines. Inconsistent Interpretation of Regulatory Guidelines Subjective interpretation of evolving global regulations leads to inconsistencies across submissions, increasing the risk of non-compliance or rejection. Multiple Data sources and distributed team Data sources are wide ranging and large (spreadsheets, and legacy tools) — making it difficult to generate accurate, timely, and auditable reports. Requires resources with various skills and experience. The Impact | High Cost, Slower Authoring, Delayed Revenue

$12M Annual Reporting Costs High Operational Spend Driven by labor-intensive authoring processes across regulatory affairs and medical writing teams.

6+ Months to finalize submission Manual drafting and fragmented review Cycles delay time-to-market, resulting in lost revenue opportunities. Increased Compliance Risk Inconsistent documentation and manual errors can expose organizations to regulatory rejections, remediation efforts, and reputational damage.

The Need | Transforming regulatory reporting from costly bottleneck to AI assisted authoring Supercharge report generation Agentic AI can automate report structure understanding; accelerate content generation utilizing data from various sources, agents to check for accuracy and completeness, and keeping human in the loop and evolve with human feedback. Value: Reduce cycle time for first draft from weeks to hours. Continuous Learning AI agents evolve over time with help from human feedback and ML based prompt tuning, making the AI system more and more efficient over time. Value: Improve submission quality and reduce regulatory rework.

Scale for features, report types, content types and enterprise governance Intelligent agents handle multimodal data, support integrations to systems and provide needed governance / guardrails Value: Boost efficiency, Improve quality, Build confidence

Agentic AI to accelerate and scale your regulatory report authoring IBM’s Agentic AI solution for regulatory report authoring simplifies draft generation in a more intelligent, traceable, and user-centric way

App Overview

Regulate-AI can supercharge regulatory report generation across life sciences, banking, ESG, and other compliance or legal reporting. Uses an advanced agentic AI approach to understand patterns, content dept and requirements using sample reports. Can connect to variety of data sources and generates an accurate and complete first draft. Works with human agent in the loop to evolved the draft in real time. Allows user and admins to configure report types, samples, data sources, context for agents and many other parameters to provide comprehensive yet easy to set use setup.

It is built on Microsoft Azure using core Azure data and AI services. It can be deployed on your Microsoft Azure cloud and can be quickly configured to set to connect to your data sources. You also have the ability to configure and adapt the agents for your business function context such as Sustainability Reporting, Financial Reporting, Safety Reporting etc.

Capabilities Agentic AI for Accuracy and Completeness Advanced agentic AI for almost every aspect, training to generation and human in the loop approach to make it super easy and effective.

Meta Learning capabilities to scale to alternative regulatory submission reports leverage training data and/or templates Simple and flexible UI Drag and drop, Multimodal support, integration with Microsoft word. Customizability Tailors to your formats, vocabularies, data source, context and workflows Transparency and monitoring Enterprise-ready with audit trails, access control, and compliance alignment (e.g., GxP, SOX, SFDR)

Features and Innovations High Quality Reports • High-Quality Output Generation (+90% overlap with human reports) • Fact-checking for correctness & completeness) • Chatbot and manual edit options

Transparency and Compliance • Regulatory Grounding of LLMs • Full transparency and traceability of AI via Chat • Human-in-the-loop process • Approach can be GxP approved

Scalable for various report types • Meta-Learning capabilities to scale to alternative regulatory submission reports • Leverage training data and/or templates

Governance and Compliance • Enterprise-grade login and authentication • Access controls • Cloud-native integration & Security • Monitoring and logs

Easy to use • Simple drag & drop functionality • Multi-modal inputs and outputs including text and tables • Integration with Microsoft Word and Veeva