A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019
Journal Title: International Journal of Trend in Scientific Research and Development - Year 2020, Vol 4, Issue 4
Abstract
Data integrity credential is a good stride to the pharmaceutical industry and also helps for the prospective market growth of the industry by increasing the public trust, reputation. Data integrity is a head way for maintaining quality systems and controlling deviations, minimizing errors that occur frequently in the industry. It ensures the lab records and good outcome in inspections, audits, and to get excellent market division in terms of share and also makes the industry flawless. Data integrity includes the complete, consistent data that should be attributable, legible, contemporaneous, and original, accurate data and should be recorded and maintained in depth periodically. This article mainly emphasizes on the approaches for data integrity, background, challenges faced by company, consequences of data integrity failures, remediation measures for data integrity, new FDA Food and Drug Administration guidelines on data integrity.In order to ensure data integrity in industry quality culture should be maintained, electronic signatures, personnel, giving training to employees to ensure quality system in the industry. Sai Sindhu P | Koushik Y | Rama Rao N "A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-4 , June 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31354.pdf
Authors and Affiliations
Sai Sindhu P | Koushik Y | Rama Rao N
Keywords
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