Risk Assessment of Data Integrity for Quality Control Process in Pharmaceutical Products based on Data Governance Framework

Authors

  • Warisa Suengtaworn School of Information Technology, King Mongkut's University of Technology Thonburi
  • Sunisa Sathapornvajana School of Information Technology, King Mongkut's University of Technology Thonburi

Keywords:

Data Governance, Data Integrity, Data Management, Quality Control, Risk Assessment

Abstract

This article reports the study of a data risk assessment for the quality control process in the pharmaceutical industry based on a data governance framework.  The drug quality control process is a critical process for the drug's release to the patient. In this process, the data integrity properties have to comply with the PIC/S standard and the related data governance frameworks such as data governance framework by DGA and GAMP data governance framework. Moreover, problems with data integrity are likely to increase in many countries. The objective of this study is to propose a data risk assessment procedure and items for ensuring the data's integrity. The procedure consists of two stages of assessment: 1) an assessment of working processes and systems, and 2) an assessment of data risks according to GAMP’s data governance framework. The risk assessment in this study were validated by pharmaceutical quality control experts and found that in the quality control process, 15 out of 63 items were at high risk. The results of the risk assessment can be used to determine the method of data management and key performance indicators for assessing the properties of data, in addition to the basic regulatory data governance framework.

References

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Published

2023-06-22

Issue

Vol. 3 No. 1 (2023): January - June

Section

Research article

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