Root Cause Analysis Using Pinnacle 21 Validation Reports: How to Improve End-to-End Programming Processs

Aakar Shah1 and Tracy Sherman2
1Nektar Therapeutics, 2Ephicacy


Abstract

As reviewers adjudicate Pinnacle 21 validation reports to address the quality of submission activities, further analysis can uncover underlying process-related issues which cause those findings in the first place. Even a single Pinnacle 21 validation report can identify underlying shortcomings. However, if you are part of large pharmaceutical company or have access to a large number of Pinnacle 21 validation reports, it can help you analyze various trends and improve all aspects of the current programming process. In this paper, we will discuss how to analyze Pinnacle 21 validation reports, categorize findings in various buckets such as Data Collection and Cleaning, SDTM Process, ADaM Process, e-Submission Process, Internal Stakeholder Management and External Stakeholder Management, and how to subsequently use root cause analysis to find and address end-to-end programming process improvement.