著者

日本 PDA 製薬学会 電子記録電子署名委員会 クラウド CSV グループ 荒井 健太郎 荒木 澄江 石川 明水 稲葉 光治 荻本 浩三 杉浦 明子 坪田 浩之 峠 茂樹 西山 宇一 平野 勝久 古市 正 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.18, no.2, pp.25-122, 2016 (Released:2016-12-20)

参考文献数

7

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It could be worthwhile to make proposals related to practical methods for CSV of cloud-based GxP business systems, given that any guidelines for CSV of those systems have not yet been issued by the Ministry of Health, Labor and Welfare. In this study, we will show development activities, verification activities and a supplier audit, all of which our group experienced, for a SaaS-type electric document management system for GxP businesses, leading to an attempt to share the best practices in CSV of cloud-based GxP business systems. The feasibility of our proposal related to the CSV life-cycle management of cloud-based GxP business systems at the previous PDA Japan Annual meeting will also be discussed in this study.