Business Problem

• SagaxTeam, a BioTech & Pharma Managed Solutions provider, specializing in IT systems Audit & Compliance, faced a daunting task. They had to rapidly scale their Pharma & Biotech IT Audit process, at the same time maintaining standards & meeting global compliances. The traditional, manual approach was marred by manual inefficiencies, was error-prone, and challenging to scale. The need for a streamlined, accurate, and scalable solution was critical for maintaining regulatory compliance and operational efficiency, to be delivered at 10X speed.

About SagaxTeam

SagaxTeam helps BioTech & Pharma firms automate IT audits and compliance, achieving 10x speed and zero-error accuracy through Generative AI.

Solution

With the complexities inherent in IT auditing for Life Sciences, SagaxTeam required a solution that could automate and standardize compliance management processes while ensuring accuracy and adaptability to regulatory changes. GoML's GenAI consulting team collaborated with SagaxTeam to harness the potential of Generative AI, leading to the creation of an advanced audit and compliance agent, which not only ensured a streamlined process, with zero – errors, but also brought down the Audit process timelines by more than 80%.

Utilize Generative AI for Data Interpretation and Context Building

Deploy Claude v3 on AWS EC2 containers to process structured and unstructured IT data, leveraging advanced LLMs for deep domain insights, system criticality assessment, and compliance needs identification.

Dynamic Risk Assessment and Documentation Generation

Integrate LYZR SDKs with RAG pipelines to dynamically assess risk and automate real-time compliance documentation generation, ensuring alignment with current regulations and system specs.

Review and Validation through User and Reviewer Portals

Implement user and reviewer portals for submitting system data and evaluating AI-generated outputs, enabling interactive validation to refine and approve compliance documents while ensuring adherence to industry standards.

Architecture

• AWS Cloud Deployment: Utilizes AWS EC2 for hosting the Sagax Server and Claude v3, which processes IT audit data using advanced AI.
• Data Processing: Sagax Server acts as the primary hub for data intake and preliminary processing, integrated with AI through Lyzr Automata for enhanced data analysis.
• Security and Automation: Incorporates GuardRails and AWS Lambda for security enforcement and process automation, ensuring data integrity and operational efficiency.
• Workflow Management: Employs AWS Step Functions to streamline the review and validation process, automating document flow between action stages and reviewers.
• API and Documentation: Uses AWS API Gateway to manage interactions between users and the system, facilitating secure document delivery.
• Monitoring and User Management: Implements AWS CloudTrail, CloudFormation, and IAM for comprehensive monitoring, logging, and user access control, supported by CloudWatch and alarms for system health monitoring. 
• Database and Notifications: Leverages RDS, DynamoDB, and SNS for robust database management and timely notifications, ensuring seamless operation and communication.