リスクベースアプローチ

FDAは、cGMPにおいて、リスクベースアプローチを推奨しています。
これは、全ての電子システムやその機能を満遍なくバリデーションやPart11の対応範囲とするのではなく、重要度の高いものから順次対応することです。
FDAが査察を実施する際に、限られた日にちでは昨今のIT時代においては、全てを調査することなど土台無理といえます。
そこで、より重要度(リスク)の高いシステムの、より重要度の高い機能から調査するという方針が出されたわけです。
このことはバリデーションを行う製薬会社側でも同様のことが言えます。
FDAにとってみれば、バリデーション作業を1から順番に対応して、ハイリスクの機能を後回しにされるよりも、例え全てではなくともよりハイリスクなものを至急対応している方が好ましいということです。
したがって、バリデーションやPart11対応を行う際には、まずリスク調査を十分に行ってから開始することが望まれます。

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