E-ISSN 2063-5346
 

Research Article 


AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES

Dharnish.R, Jeyaprakash M.R.

Abstract
Data Integrity assures that the information is traceable, readable, current, unique, and correct. It is an essential
aspect of the industry's obligation to assure the safety, efficacy, and quality of their products. In pharmaceutical industry it
plays a vital role and it is an important current issue for regulators around the world. During inspections a multiple of
problems being found by the pharmaceutical regulatory agency all over the world. There are many regulatory guidelines on
data integrity. The objective of this study carries number of issues involved within data integrity in current GMP aspects, the
root causes were addressed grounded on warning letters. In this article we study about types, advantage and disadvantage,
factors affecting, ALCOA concept, and their limitations.

Key words: Data integrity, ALCOA, WHO, Retrieval and storage.


 
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Pubmed Style

Dharnish.R, Jeyaprakash M.R. AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. ECB. 2023; 12(1): 19-24. doi:10.31838/ecb/2023.12.1.002


Web Style

Dharnish.R, Jeyaprakash M.R. AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. https://www.eurchembull.com/?mno=141752 [Access: January 25, 2023]. doi:10.31838/ecb/2023.12.1.002


AMA (American Medical Association) Style

Dharnish.R, Jeyaprakash M.R. AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. ECB. 2023; 12(1): 19-24. doi:10.31838/ecb/2023.12.1.002



Vancouver/ICMJE Style

Dharnish.R, Jeyaprakash M.R. AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. ECB. (2023), [cited January 25, 2023]; 12(1): 19-24. doi:10.31838/ecb/2023.12.1.002



Harvard Style

Dharnish.R, Jeyaprakash M.R (2023) AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. ECB, 12 (1), 19-24. doi:10.31838/ecb/2023.12.1.002



Turabian Style

Dharnish.R, Jeyaprakash M.R. 2023. AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. European Chemical Bulletin, 12 (1), 19-24. doi:10.31838/ecb/2023.12.1.002



Chicago Style

Dharnish.R, Jeyaprakash M.R. "AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES." European Chemical Bulletin 12 (2023), 19-24. doi:10.31838/ecb/2023.12.1.002



MLA (The Modern Language Association) Style

Dharnish.R, Jeyaprakash M.R. "AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES." European Chemical Bulletin 12.1 (2023), 19-24. Print. doi:10.31838/ecb/2023.12.1.002



APA (American Psychological Association) Style

Dharnish.R, Jeyaprakash M.R (2023) AN APPROACH OF DATA INTEGRITY IN PHARMACEUTICAL INDUSTRIES. European Chemical Bulletin, 12 (1), 19-24. doi:10.31838/ecb/2023.12.1.002