PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Topics Review
Regulatory compliance practices for data integrity
DI Promotion Working Group in ERES Committee, PDA Japan ChapterIkumi AbeHisao NagataKenichi OgiharaKatsuhiro HashimotoHisashi KatoKenichi HashimotoAkiko SugiuraRyuji FutenmaJun TakahashiNorioki MasaiSachio TakedaKuniyuki SakuraiMakoto TanigawaYutaka Maeda
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Supplementary material

2022 Volume 24 Issue 1 Pages 10-22

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Abstract

Although the regulatory requirements for data integrity are appropriately described in the relevant guidelines, the question can naturally be raised on how to afford the industry for their implementation. Hereof, it is worth advancing some proposals for concrete measures of data integrity remediation so that the industry could enforce the compliance without ambiguity in the above regulation specified by the authorities. In this study, we will introduce practical methods for time adjustment, hybrid, and audit trail review in the perspective of data integrity and attempt to share best practices for regulatory compliance regarding data integrity. The study will also detail all the points of time adjustment, hybrid, and audit trail review described at the “DI Remediation Practical Seminar” held in July 2021.

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© 2022 Parenteral Drug Association Japan Chapter
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