なぜデータインテグリティは企業にとってハードなのか
データインテグリティに関心が高まっている。
しかしながら、各社ともデータインテグリティ対応に手こずっているのが現状ではないだろうか。
データインテグリティ対応が企業にとってハードである理由は下記の通りである。
- パフォーマンスおよびビジネスプレッシャー
- 気付きの欠如や能力不足
- DIが企業文化に根付いていない
- 不適切なプロセスおよびテクノロジー
パフォーマンスおよびビジネスプレッシャー
各企業とも、医薬品開発、医薬品製造等に追われている。企業であるため、売上や利益を追求することはやむを得ない。しかしながら、ビジネスを優先するあまり、データインテグリティ対応がおざなりになってしまっている。
気付きの欠如や能力不足
自身の作業がどの程度データインテグリティに関わっているのかを認識していない。またデータの信頼性を損ねた場合、患者や被験者にどのような健康被害が及ぶのか、申請資料の信頼性に関わるのかといったような事項に思いが馳せることがない。
まずは、従業員すべてがデータインテグリティの重要性について気付きを得ることが重要であろう。
しかしながら、データインテグリティの重要性に気付いたとしても、ダブルチェックするだけの要員が足りなかったり、そもそもデータの間違い等を抽出するだけの能力（知識・経験）がないこともある。
DIが企業文化に根付いていない
今、目指すべきは“Quality Culture”の醸成である。役員以下、すべての従業員がデータインテグリティを重要視する文化を持たなければならない。
筆者はコンサルテーションを通じて、多くの企業のSOPを見てきた。その際に「なぜこのようなプロセスになっているのか」と尋ねることがある。多くの場合「何故かは知らないが、当社ではかなり前からそのように作業することになっているようだ。」といった回答が返ってくる。
これではデータインテグリティ対応はできない。
必要なことは、時間や労力をかけ、SOPを継続的に改善し、あらゆるリスクを軽減させなければならないのである。従前の手順の通り実施していれば問題ないといったような風潮は改めなければならないのである。
不適切なプロセスおよびテクノロジー
上述の通り、SOPにおいてあらゆるリスクを軽減しなければならない。
多くの企業では、順当に進むことを前提とした手順になっていないだろうか。
データインテグリティ対応で重要なことは、順当には進まないケースを想定することである。
例えば、「転記する」といったプロセスがあれば「転記ミス」といったリスクが考えられる。
「計算する」といったプロセスがあれば「計算ミス」といったリスクが考えられる。
「入力する」といったプロセスがあれば「入力ミス」といったリスクが考えられる。
それらを発見し問題の発生を防ぐためには、例えばダブルチェックを実施するなどが考えられるだろう。
リスクを考慮していない現状のプロセスを早急に見直さなければならない。
またMS-Excelにおいては、セキュリティリスクや監査証跡リスクがある。
さらに電子天秤、TOC、PHメータなどのシンプルなシステムは、データベースと直接接続されておらず、ヒトが介在した転記作業を伴う。
このように不適切なテクノロジーを使用していること自体も、データインテグリティ対応に後れを取っているのである。
対応すべきはヒューマンエラー
ここで興味深いデータを紹介しよう。
データインテグリティ違反を犯す最大の原因は「うっかりミス」である。つまりヒューマンエラーなのである。 なんと「うっかりミス」を原因とするデータインテグリティ違反は全体の80%を占めるのである。
残り20%は「故意による変更」である。ただし「故意による変更」といっても“悪意”があるとは限らない。
当該本人は正しいと思ってデータを訂正しているが、訂正が間違いであることもあるのである。
これは思い込み、勘違い、教育不足などから発生する。
規制当局の講演を聞いていると“不正防止”について力説している。そのため多くの企業では、データインテグリティ対応とは不正の防止であると勘違いしていることが多いように思われる。
しかしである。世の中でそんなに“不正”が日常茶飯事なのであろうか。
まず対応すべきなのはヒューマンエラーではないだろうか。
また、多くのデータインテグリティに関するセミナー等を聞いていると、電子記録のセキュリティにばかり言及している。
データインテグリティ対応は、電子記録のみではない。紙記録（手書きの記録）に対しても等しく対応が望まれる。
果たして、電子記録の改ざんと紙記録の改ざんでは、どちらの方が患者にとって重大であろうか。 どちらも同じである。
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