Smart Labeling: AI-Powered Patient Information Leaflet Automation on Microsoft Azure

HCLTech’s Smart labeling is a transformative, AI-based solution to automate the creation of Patient Information Leaflets (PILs) from Summary of Product Characteristics (SmPCs), reducing manual effort, improving compliance, and accelerating turnaround times. Built on Microsoft Azure, the solution leverages Azure AI, NLP, and machine learning to intelligently extract, classify, and map scientific content into patient-friendly language.

Key Competencies

1. Life Sciences & Regulatory Compliance - Strong expertise in global labeling standards (EMA, FDA) with deep domain knowledge in biopharma regulatory processes.

2. Azure AI & Machine Learning -Skilled in leveraging Azure AI services and Azure Machine Learning to automate labeling workflows and content generation.

3. Natural Language Processing (NLP) - Proficient in applying NLP for transforming SmPCs into readable, compliant PILs using Azure Cognitive Services.

4. Cloud-Native Architecture -Experience building secure, scalable solutions using Azure Functions, Storage, and App Services.

5. Process Automation - Automation of labeling processes using Microsoft Power Automate and Azure Logic Apps.

6. Template & Localization Management - Efficient handling of dynamic, multilingual templates through SharePoint Online and Microsoft 365 integration.

End-to-end Services on the Smart Labeling solution on Azure

1. Intelligent auto-mapping of SmPCs to PILs using AI and defined transformation rules

2. Template management for regional label variations

3. Readability scoring with Flesch-Kincaid standards

4. Integration with document management systems

5. User training, support, and documentation

Customer Benefits:

1. Over 40% reduction in labeling processing time

2. 60%+ improvement in global and regional compliance

3. Increased productivity and streamlined capacity planning

4. Ideal for life sciences and biopharma organizations, this solution ensures consistent, accurate, and regulatory-compliant labeling—powered by Microsoft cloud technologies.

HCLTech offers Assessment and Consulting service covering the following activities,

a. Assess current business process

b. Assess application landscape

c. Define the scope and use-cases for implementation

d. Define MVP objectives and scope

e. Define Gen-AI Governance Guardrails

f. Define target architecture and design

g. Prepare implementation roadmap

These activities are estimated to take 2 weeks.

The assessment phase is followed by implementation of the MVP, Rollout and end-user support.