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.

Goal

To generate a cross-industry audit methodology that relies heavily on data analytics, allowing auditors to analyze large volumes of data in a short period of time and draw conclusions based on evidence. By tailoring the objective questions of the RAPID audit and utilizing specific data analytics packages, the RAPID methodology will be designed to focus on key areas of risk and provide insights into the effectiveness of GCP and GVP processes and the compliance state of clinical development and marketed products.

Expected Outcomes

  • Establish a cross-industry RAPID methodology.
  • Develop job aids and templates for implementation by IMPALA members.
  • White paper on RAPID methodology, including an assessment of impact of the methodology based on IMPALA members’ experience.
  • Conference presentation on an innovative approach to managing quality.

Lead(s)

Resources

  • Working area (Members only access)

On this page:

Status:

Category:

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.

  • GenAI for Audit Report Drafting

    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.