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)