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A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019

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A Perspective Study of Warning Letters on Data Integrity Issued by FDA between 2017 and 2019


Sai Sindhu P | Koushik Y | Rama Rao N



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, pp.1025-1031, URL: https://www.ijtsrd.com/papers/ijtsrd31354.pdf

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.

Close out letters, Data integrity failures, New FDA guidelines, Quality culture, Risk factors


IJTSRD31354
Volume-4 | Issue-4, June 2020
1025-1031
IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470
Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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