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Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)

Editor-in-Chief

ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Raw Data Management and Data Integrity in Pharmaceutical Product Development

Author(s): Jenish Parmar, Priti Mehta*, Rajvi Patel, Manan Shah and Charmy Kothari

Volume 7 , Issue 3 , 2020

Page: [197 - 205] Pages: 9

DOI: 10.2174/2213476X07999200901110354

Price: $65

Abstract

In pharmaceuticals, raw data management is a tedious process that comprises of obtaining the data, affirming the validity, and preserving the required data to make certain of the quality, accuracy, and timeliness of the one who is using the data. Raw data management makes processing, validation, and other essential functions simpler and less time intensive. It provides actual information, i.e., the information which has not undergone any processing either manually or through an automated system. Raw data are managed by looking into integrity issues, such as document falsification, failure to provide adequate controls, and taking appropriate measures for its prevention. Also, access to the computer system should be restricted to authorized personnel only. There should be shared just-read client accounts that will stop the sharing of important data to personnel other than the authorized one. Prevention and management include training, good documentation practice, self-inspection, management strategy, and global corrective and preventive actions. Also, a good moral practice should be taught to the employees who are into documentation work.

Keywords: Data, meta data, data integrity, audit trail, original records, electronic signature.

Graphical Abstract
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