著者

日本PDA製薬学会 電子記録・電子署名(ERES)委員会 データインテグリティ分科会 DI対応進め隊 阿部 いくみ 永田 久雄 荻原 健一 橋本 勝弘 加藤 尚志 橋本 剣一 杉浦 明子 普天間 竜治 高橋 潤 政井 宣興 武田 幸雄 櫻井 國幸 谷川 誠 前田 豊

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.24, no.1, pp.10-22, 2022 (Released:2022-06-22)

参考文献数

6

---

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.