FDA QSR (21 CFR Part 820)
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Headline
Headline
Headline
2019.02.18
Quality System
組織とは
2019.03.01
Design Control
設計バリデーション(設計の妥当性確認)とは
2023.11.18
未分類
Competence Table and Training Needs
2018.06.24
CSV
規制要件とは
2020.09.03
FDA
2 QSR関係20150618 21 CFR 820 QSR概要
2020.06.10
Medical Device
『MDRの最新スケジュール』
2019.02.18
21 CFR Part 801 LABELING
21 CFR Part 801 Labeling
2016.10.17
ERES
タイプライターイクスキューズについて
2022.09.13
CSA
[Preliminary] FDA’s Draft CSA Guidance Issued on September 13, 2022.
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ユーザビリティ
Applying Human Factors and Usability Engineering to Medical Devices(邦訳版)
2021.10.25
Pharmaceutical
Purpose of PQ
2023.02.20
Part11
Issues related to long-term preservation of electronic records
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FDA QSR (21 CFR Part 820)
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