Case study
AI-Powered SOP Rewriting Interface for Regulatory Compliance and Document Quality
To enhance regulatory adherence, document clarity, and operational efficiency by implementing an AI-based web platform for SOP evaluation and rewriting—addressing variability, complex language, and manual review bottlenecks in Biocon’s document processes.
Table of contents
Business objective
To enhance regulatory adherence, document clarity, and operational efficiency by implementing an AI-based web platform for SOP evaluation and rewriting—addressing variability, complex language, and manual review bottlenecks in Syngene International Limited’s document processes in India.
Solutions & implementation
Developed a web-based Generative AI application using ReactJS (frontend) and Django (backend) hosted on AWS EC2.
Integrated Amazon S3 for document storage and Amazon RDS (PostgreSQL) for prompt templates and revision history.
Used prompt engineering to transform SOPs with LLM responses via Amazon Bedrock (Claude 3 Sonnet).
Supported manual import of revision inputs (from emails or MS Teams) into a versioned revision tracker.
Enabled tracked changes, structural rewriting, grammar checks, and export-ready outputs aligned to DMS formats.
Ensured CFR audit readiness through version control, traceability, and compliance reporting.
Major technologies used
Amazon Bedrock (Claude 3 Sonnet)
LLM for rewriting SOPs
Amazon S3, EC2, RDS (PostgreSQL), AWS Textract, Amazon MQ
Scalable AWS infrastructure
ReactJS, Django, Python
Application logic and front-end
LangSmith, Pinecone
Prompt engineering and semantic vector storage
AWS Athena, Presto
For future extensibility of SOP data querying
Business outcomes
Streamlined SOP Rewriting and Review Workflow
Enabled structured, tracked rewriting and feedback within a single AI interface, reducing manual document iterations.
Improved SOP Quality and Readability
Rewrote SOPs using consistent tone, improved grammar, and standardized structure across all operational sites.
Audit-Ready Change Traceability
Integrated revision tracking, version control, and compliance feedback mechanisms aligned to CFR standards.
Foundation for AI-Enabled Regulatory Compliance at Scale
Built a scalable GenAI-enabled platform ready for Phase 2 features like FDA guideline validation, automated compliance scoring, and integration with Biocon’s SOP DMS.
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