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[…] FDAはしばしばState of Controlという用語を使用する。ICH Q10においてもこの用語が用いられている。上記のハインリッヒの法則、ブロークンウィンドウ理論、ゆでガエル現象などの教訓から、企業の品質管理、品質保証について”管理された状態”に保たなければならないのである。FDA査察等において、企業が経営者のポリシーのもと、品質システムが構築され、管理された状態(State of Control)であるかどうか調査されるのである。 管理された状態である企業は、安心な企業と言える。 […]
[…] FDAはしばしばState of Controlという用語を使用する。ICH Q10においてもこの用語が用いられている。上記のハインリッヒの法則、ブロークンウィンドウ理論、ゆでガエル現象などの教訓から、企業の品質管理、品質保証について”管理された状態”に保たなければならないのである。FDA査察等において、企業が経営者のポリシーのもと、品質システムが構築され、管理された状態(State of Control)であるかどうか調査されるのである。 […]
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