IMPORTANCE OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRY
Keywords:
Data Integrity, USFDA, Health Canada, EMEA, ALCOA.Abstract
We attempted to research data integrity and application in the pharmaceutical industry in this essay. Data integrity must be used to maintain all records in the pharmaceutical sector.
The integrity of data is a crucial contemporary concern for authorities all around the world. Numerous issues are discovered by the pharmaceutical regulating body during inspections as a result of inadequate practices that result in subpar products for patients. Data is the result of the compilation of numerous forms of information and outcomes. As one of an organization's most precious resources, this data is of little use if it lacks integrity. The likelihood of an organization's stability and performance is increased by accuracy and original data.
The degree to which all data are comprehensive, consistent, and accurate throughout the life cycle of the data is known as data integrity. Data integrity refers to the accuracy of all original records, including source data and metadata that may be stored electronically or on paper. Many regulatory authorities, including the USFDA, Health Canada, and EMEA, suggested using ALCOA to ensure the data integrity (Attributable, Legible, Contemporaneous, Original and Accurate).
