Applying SQC to adverse event report processing function in Pharmacovigilance: Managing the quality of data entry in the database

Dr Ajinkya C. Inamdar; Dr Arati A. Inamdar

Volume : VII, Issue : II, February - 2018

Applying SQC to adverse event report processing function in Pharmacovigilance: Managing the quality of data entry in the database

Dr Ajinkya C. Inamdar, Dr Arati A. Inamdar

Abstract :

�Statistical Quality Control (SQC) is widely applied in many industries, but its use in adverse event report (AER) processing in pharmacovigilance (PV) has been limited. We advocate implementation of SQC application model for data entry in PV considering the fact that the data is utilized for analysis of a drug�s performance and to submit individual and aggregate reports to regulatory authorities. Considering the impact of quality of data on the decision making, it is extremely important to manage the quality of data in a safety database. There are 5 steps in application of SQC; define, measure, analyze, improve and control. In this report, we explain how to apply Six Sigma to AER processing in Pharmacovigilance. We also present a benchtop method for implementation of SQC at any case processing operation. SQC is important now than ever because the data entry work can be outsourced.