2011 Fiscal Year Final Research Report
A Study of Integrated Computerized System Validation Method for Drug Manufacturing Computerized System
| Project/Area Number |
21500439
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Medical systems
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| Research Institution | University of Yamanashi |
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Principal Investigator |
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| Project Period (FY) |
2009 – 2011
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| Keywords | GAMP5 / 予測的コンピュータ化システム・バリデーション / 回顧的コンピュータ化システム・バリデーション / 設計情報トレーサビリティ / FMEA / PLC / バリデーション作業高精度化 / バリデーション作業効率化 |
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| Research Abstract |
Computer Systems related drug manufacturing are required to prove the adequacy of their functions and performance by the regulatory authorities. This is called as Computerized System Validation(CSV). We defined the CSV procedure and developed a CSV support environment to conduct CSV adequately and efficiently in this study. As a result, we could conduct CSV without mistakes and reduce working time 20%.
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