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Vol. 8, Issue 1 (2019)

Importance of data integrity & its regulation in pharmaceutical industry

Author(s):
Shmmon Ahmad, Ashok Kumar and Dr. Abdul Hafeez
Abstract:
Data integrity is an important current issue for regulators around the world. During inspections a multitude of problems being found by the pharmaceutical regulatory agency because poor practices develop the substandard product for patients. Collection of various types of information and results collectively made in the form of data. This data becomes one of the most valuable assets of any organization but without integrity, this data is not much useful. Accuracy and original data increase the chances of stability and performance of an organization.
Data integrity is the extent to which all data are complete, consistent and accurate throughout the life cycle of data. It includes Good Documentation Practice which leads to preventing data from being altered, copied or moved. In data integrity, data means all original records including source data and metadata which may be recorded in paper or electronic form. To assure the data integrity many regulatory bodies such as USFDA, Health Canada, and EMEA recommended the use of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate).
Pages: 306-313  |  504 Views  50 Downloads
How to cite this article:
Shmmon Ahmad, Ashok Kumar, Dr. Abdul Hafeez. Importance of data integrity & its regulation in pharmaceutical industry. Pharma Innovation 2019;8(1):306-313.
The Pharma Innovation Journal