データインテグリティはセキュリティと監査証跡で十分か

データインテグリティはセキュリティと監査証跡で十分か

データインテグリティと21 CFR Part 11を混同しているケースが多い。つまり、データインテグリティは電子記録に対する信頼性の保証だと誤解しているのである。
データインテグリティの原則は、電子記録と紙媒体の記録の両方に等しく課される。
ここで読者に質問である。

『電子記録の改ざんと紙記録の改ざんではどちらの方が患者の安全性にとって重要であろうか?』

答えは『同じ』である。

データインテグリティ対応では、電子記録の信頼性に重点をおいている企業が少なくない。
データインテグリティと21 CFR Part 11を混同している訳である。

セキュリティや監査証跡でデータインテグリティが保証できるか

データインテグリティ違反の80%までがヒューマンエラーであるという報告がある。
しかしながら、多くのセミナーや講演を聞いていると、コンピュータシステムのセキュリティ対策や、監査証跡機能のある機器への買い替えなどの内容がほとんどである。
では、セキュリティや監査証跡機能を設ければ、ヒューマンエラーは防げるのであろうか?

答えは“否”である。

データインテグリティを保証するためには、故意か事故かに関わらず、電子記録および紙媒体の記録のあらゆる意図しない変更からオリジナルのデータを保護することが重要である。

21 CFR Part 11は改定されない!?

おそらく21 CFR Part 11はこの先、改定されることはないだろう。
その理由は電子記録に特化していることや、上述の通りヒューマンエラーを防止することが出来ないためである。
また21 CFR Part 11は『如何に不正を防止し、如何に不正を発見するか』に終始している。
不正はあってはならない。しかしながら、いったい多くの記録の中で不正により改ざんされているものが全体のうちどれくらいを占めているというのであろうか。
『不正が出来ない』≠『データインテグリティが保証できている』である。 データインテグリティでは、ヒューマンエラーを防止し、ダブルチェックし、信頼性を保証しなければならない。これでまずはデータインテグリティ違反の80%をカバーできるのである。

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