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Practice for CSV of Cloud-Based GxP Business Systems:
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- Arai Kentaro
- Olympus Corporation
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- Araki Sumie
- KYOWA PHARMA CHEMICAL CO., LTD.
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- Ishikawa Akemi
- KISSEI COMTEC Co., Ltd.
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- Inaba Koji
- KISSEI COMTEC Co., Ltd.
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- Ogimoto Kozo
- Shimadzu Corporation
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- Sugiura Akiko
- Fuji Xerox Information Systems Co., Ltd.
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- Tsubota Hiroyuki
- Chiyoda Corporation
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- Toge Shigeki
- Sumitomo Dainippon Pharma Co., Ltd.
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- Nishiyama Uichi
- Kyowa Hakko Kirin Co., Ltd.
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- Hirano Katsuhisa
- CTC Life Science Corporation
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- Furuichi Tadashi
- Azbil Corporation
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- Maeda Yutaka
- CHUGAI PHARMACEUTICAL CO., LTD.
Bibliographic Information
- Other Title
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- クラウドを利用した GxP 業務システムの CSV 実践
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Description
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.<br>
Journal
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- PDA Journal of GMP and Validation in Japan
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PDA Journal of GMP and Validation in Japan 18 (2), 25-122, 2016
Parenteral Drug Association Japan Chapter
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Details 詳細情報について
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- CRID
- 1390282679448246528
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- NII Article ID
- 130005251331
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- ISSN
- 18811728
- 13444891
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed