New workstream focused on leveraging Generative AI (GenAI) to support the drafting of audit findings . This initiative is part of a broader shift from exploratory discussions to structured implementation of GenAI in quality assurance.

Goal

To share the approach, key learnings, benefits and considerations when implementing GenAI for drafting audit reports, giving other biopharma companies a head-start in doing the same.

Expected Outcomes

  • White paper which will describe best practices and technical implementation guidance for using GenAI to generate the first draft of audit report content. Additional topics include use case identification/scoping, value definition, guardrails, risks, and infrastructure needs.
  • Connections with additional future white papers on leveraging GenAI on topics such as validation
  • Leveraging of additional channels such as podcasts, industry conferences, and connections to existing IMPALA work.

Lead(s)

Resources

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Related Work Products

  • GenAI Validation Guidance

    With the increasing use of Generative AI in the pharmaceutical industry, and the evolving regulations and guidance from various regulatory authorities, IMPALA aims to outline some key principles and guidelines helping the industry to adopt GenAI while assessing the risks and establishing the right controls to ensure safe use.

  • Critical to Quality Assessment

    A change in the Quality paradigm to reduce the burden of retrospective, time-consuming traditional QA activities, and ultimately accelerate approval and patient access to innovative products.

  • RAPID Audit Methodology

    Real-time Audit Package informed by Data (RAPID) is a data-driven approach that follows a pre-defined methodology to assess processes and identify systemic issues efficiently.