電子が正か紙が正か

電子が正か紙が正か

筆者がコンサルテーションを実施する中で、しばしば以下のような主張を聞く。
「当社では、責任者が記録を十分に精査して、署名（捺印）を行っている。したがって、紙が正（原本）である。」
しかしながら、この主張は、性善説に基づくものである。
おおよそ欧米の規制当局の査察は、性悪説をもとに実施される。
もし当該企業で、OOSによる製品の廃棄や回収事案等の重大な品質問題等が発生した場合、経営者（責任者）が、経済的な観点から不正（データの改ざん）を指示することになるからである。
一般に担当者は不正を行わない。なぜならば、不正を行うといったモチベーションもなければ、不正によるインセンティブもないからである。
したがって、上記のように「責任者が記録を十分に精査して、署名（捺印）を行っている。」という主張では当局は納得しないのである。

タイプライターイクスキューズ

かつて21 CFR Part 11が発行された後に米国でこんな議論があった。
製薬企業が次のように主張した。
「真の記録は紙の記録である。我々はコンピュータを単に記録を作成するために使っているに過ぎない。」
つまり、当該コンピュータは、タイプライターのように使用しているので、Part 11の対象ではないという主張である。
この主張を「タイプライターイクスキューズ」と呼んでいる。
FDA はこれに対し、「たとえば電子記録が作成されない場合のように、コンピュータが本当にタイプライターのように使用されている時のみ、Part 11は適用されない。」と見解を述べた。
タイプライターとコンピュータでは、大きな相違点があるためである。
タイプライターの特徴は「One Time Printing」である。つまり、一度しか印字できないのである。
これに対し、コンピュータは電子記録を保持するため、何度でも印刷することができる。
このことを利用して、電子記録を改ざんし、再印刷した上で、バックデートで署名するといった不正が可能になってしまうのである。

当時Part 11を主宰していたPaul Motiseは、以下のように述べている。
「プリントアウトを本質的に信頼することはできない。なぜならプリントアウトにはデータの再構築または生データから再現するために必要なメタデータ情報を含んでいないからである。」
つまり、紙媒体上には監査証跡がなく、改ざんされた記録であるかどうかが確認できないという事である。

気を付けなけらばならないことは、”ハイブリッドシステム（電子記録＋手書き署名）は、署名（記名・捺印）を紙媒体化したのみであり、記録は電子である。”という事である。
ハイブリッドシステムの場合、規制当局は査察時に、記録を電子で調査し、署名を紙で確認するのである。
その目的は、改ざんの発見である。
したがって、紙媒体で承認（署名）したからといって、けっして電子記録を消去 してはいけないのである。
なぜならば電子記録が正だからである。

関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
・【超入門】コンピュータバリデーション＆ER/ES
・【中級編】コンピュータバリデーションセミナー
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