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AI Chatbots to Support GxP Content for Clinical Trials


Learn how USDM helped a Top 5 global pharmaceutical company create a validated Artificial Intelligence (AI) framework for Microsoft Azure and accelerate the migration of its regulated workload to the cloud.

Cloud technology has never been more critical to the success of life sciences businesses. Yet the heavily regulated environment poses concerns to IT and quality leaders needing to advance their operations. USDM enabled this pharmaceutical company to unleash the power of Microsoft Azure to speed up and advance their clinical trials using AI chatbots.

The Situation
  • Top 5 global pharmaceutical company
  • Products available in 155 countries
  • No formal Software Development Lifecycle (SDLC) was in place to govern the Azure DevOps tool in the tech stack
  • There were no computer system validation (CSV) or standard operating procedures (SOPs) specific to DevOps (the assumption was that global CSV and SOPs would apply)
  • The Microsoft Azure infrastructure is already qualified for non-GxP use
  • The intent is to use the DevOps framework for a pilot program to develop chatbots for automated assistance
    • The chatbots were non-GxP and used Azure and natural language processing (NLP) tools
    • USDM was asked to develop chatbots that could be used to provide GxP content to their clinical sites
  • Concerns using DevOps for GxP:
    • Lack of sequence-of-steps enforcement
    • Limited approval functionalities
    • Lack of understanding on how best to use DevOps tools to meet GxP validation requirements
The Solution
  • USDM built a continuously compliant infrastructure to scale AI bot uses for faster innovation
  • USDM helped customer with an AI pilot program using Azure Stack and NLP tools to develop chatbots for GxP content that would support clinical trials
  • USDM developed a governance structure and workflows to support GxP use cases
  • USDM educated the customer on DevOps framework best practices to meet GxP validation requirements
  • USDM solved for using electronic signatures natively in Azure to manage approvals; this saved time by avoiding custom development work
  • USDM developed a master assurance plan (MAP) that distinguished GxP, non-GxP, and Software as a Medical Device (SaMD) to differentiate between formal testing and informal testing and meet global regulatory requirements

The Results

  • AI chatbots deliver GxP content at clinical sites
  • eSignatures delivered natively in Azure to manage approvals
  • Faster innovation achieved in clinical trails by qualifying Azure DevOps

Learn more about USDM’s GxP solution for your Azure tech-stack.


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