Data Integrity and Worldwide Regulatory Guidance

  • Posted on: 30 April 2016
  • By: admin



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May 2016 ARTICLE LIST >>

PharmaTutor (May- 2016)


Print-ISSN: 2394 - 6679
e-ISSN: 2347 - 7881
(Volume 4, Issue 5)


Received On: 26/11/2015; Accepted On: 10/12/2015; Published On: 01/05/2016


Rohit A. Patil, Shruti N.Patil
Department of Regulatory Affairs
Supreme Pharma Healthcare Pvt. Ltd. Mumbai


ABSTRACT: Good storage of data & record management are critical elements of pharmaceutical quality system. Data integrity refers to maintaining & assuring the accuracy & consistency of data over its entire life-cycle in compliance with its applicable regulatory requirements. Data integrity is mandatory for the regulated pharmaceutical industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Data integrity risk should be assessed, mitigated, communicated & reviewed throughout the data life cycle. Healthcare industries should be designed Record-keeping methodologies and systems, in a way that encourages compliance and assures data quality and reliability.


How to cite this article: Patil RA, Patil SN; Data Integrity and Worldwide Regulatory Guidance; PharmaTutor; 2016; 4(5); 20-24