AgenticWorks RepoGen

AgenticWorks RepoGen is built on an AI Agent–driven architecture that automates statistical calculations and quality analysis to generate draft reports. It supports event management across production processes—defects, returns, and deviations—through issue analysis, root cause investigation, and CAPA (Corrective and Preventive Actions). The service validates specification changes, conducts trend and product/process analyses to identify root causes, and performs re-validation or process requalification when necessary.

The service consists of specialized AI agents:

Result Summary Agent: extracts and summarizes data, reducing report drafting time by over 90%.

Analytics & Statistics Agent: performs data-driven analysis and generates visualizations for accuracy.

Comprehensive Summary Agent: consolidates evaluations and monitoring results into consistent, compliant reports.

Key benefits for customers include:

Faster reporting with over 90% reduction in manual effort

Higher accuracy through self-validation and automated analytics

Consistent quality using standardized templates for audits and regulatory submissions

Running on AWS-native architecture, AgenticWorks RepoGen deploys multiple AI agents on Amazon EKS. Generative AI agents powered by Amazon Bedrock automate planning, execution, and evaluation. Amazon ElastiCache improves responsiveness and cost efficiency, while Amazon S3 and Amazon RDS ensure data consistency and session continuity. Amazon Athena and OpenSearch enable scalable analytics and accurate search, and Amazon Cognito provides secure user authentication.

Through these capabilities, AgenticWorks RepoGen empowers pharmaceutical and manufacturing enterprises to innovate quality management, ensure regulatory compliance, and enhance productivity with an intelligent, data-driven platform.