DHFの原則
各機種の設計に対して設計履歴ファイル(DHF)を作成し保存すること。
DHFには、計画書で定義されている設計に関するすべての記録を保持すること。
設計開発は、設計計画書に基づいて実施されたことをDHFの内容により証明できること。
DHFは、設計のInput、Output、Design Review、Verification、Validationの各時点での成果物を登録すること。
Input、Output、Design Review、Verification、Validation結果を承認すること。
FDAのワーニングレターの事例
貴社は設計が承認された設計計画および21 CFR 820の要求に従ってなされたということを示すための必要な記録を含み、参照するための設計履歴ファイル(DHF)を確立および維持していない。
- 参考
21 CFR Part820 Quality System Regulation, FDA 1997
Design Control Guidance For Medical Device Manufacturers, FDA 11 March,1997
FDA査察対応設計管理手順書サンプル
イーコンプライアンスでは、FDAが要求する設計管理に対応した、規程、手順書、様式のサンプルを販売しています。
ぜひご購入をご検討下さい。
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