https://store-images.s-microsoft.com/image/apps.57653.902e0257-f81a-483f-97c3-98aa9c10450d.7b49ba18-11fd-4d18-8754-0c3b77faeba5.d5d4e639-cf73-452f-87e9-0abf3b0d9d13

LTIMindtree_Data And AI SmartVal_Computer System Validation

LTIMindtree Limited

Pricing Free

LTIMindtree offers SmartVal, an AI powered solution that helps life sciences companies rapidly ensure computer system compliance by reducing validation time, effort, and overall compliance costs.

Computer System Validation (CSV) is essential for life sciences organizations to ensure that GxP systems operate consistently as intended and protect product quality, patient safety, and data integrity. CSV involves documented evidence that a computer system meets defined requirements and performs accurately, reliably, and consistently throughout its lifecycle.

Challenges

  • During the project initiation phase, validation leads must perform an initial risk assessment that incorporates GxP determination, overall business risk, system impact, and other factors. The outcomes of these risk assessments inform the level of validation documentation and testing required for the computer system.
  • Failure to apply a risk-based approach results in excessive validation, increasing operational burden and costs.
  • Additionally, paper-based and manual validation processes are slow, resource-intensive, and prone to human error.
  • Inability to perform comprehensive risk assessments can lead to significant harm to patient safety and data integrity.

    • Solution Approach

  • Using large language model (LLM) as the core reasoning engine, the multi-agent pipeline performs web search, regulatory validation, and document generation, with domain knowledge infused at each decision step.
  • The system assesses the computer system’s data privacy requirements and determines the SOX and GxP applicability by leveraging contextual information and standardized enterprise checklists.
  • It uses industry-standard templates and best practices to create first drafts of key deliverables such initial risk assessment forms, validation master plan and functional requirement specifications.
  • Built on Microsoft Azure OpenAI LLM and using Azure Foundry technology, the agents deliver detailed reasoning and contextual insights behind each response.
  • Use built-in safeguards and prompt guardrails to ensure responsible and secure interactions while maintaining both accuracy and trust.

    • Benefits

  • Time Savings: Increased productivity by significantly reducing the time required to create and review documents.
  • Cost Reduction: Lower costs related to manual document creation.
  • Faster Time to Market: Accelerated regulatory submissions and approvals.

    • At a glance

    https://store-images.s-microsoft.com/image/apps.47492.902e0257-f81a-483f-97c3-98aa9c10450d.7b49ba18-11fd-4d18-8754-0c3b77faeba5.ad6b063e-6958-4aa8-9ec4-b192714c9697