Data Integrity Implementation Strategy for Pharma Industry

Abstract

Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality as decisions on product quality are made based on the data. Electronic data and computerized systems have introduced new challenges to maintain data integrity; hence the data governance system should be integral to the pharmaceutical quality system as required by regulatory authorities as Food and Drug Administration (FDA) and Healthcare Products Regulatory Agency (MHRA). Data integrity requirements apply equally to manual (paper) and electronic data. The regulatory authorities have put much emphasis on data integrity in recent years because they uncovered serious cases of data integrity breaches. This project supports the pharma industry goal and success of operational excellence with zero FDA’s alerts related to Data Integrity. This should also be a model to all plant sites within the same problem and avoid CGMP’s violations or issues involving data integrity. Key Terms - ALCOA, Data Integrity, ERES, GMP’s.