MS-Excelによる 電子記録管理の問題点について

医薬品業界や医療機器業界では、MS-Excelによって記録を作成したり保存していることが多いのではないだろうか。

しかしながら、Excelによる記録の管理には、以下の問題点がある。

  1. 監査証跡がとれない
  2. セキュリティの問題(パスワードが入力できない)
  3. 入力データの自動チェックができない
  4. 印刷時に、欠け、はみ出しが起きる
  5. 有効桁数の問題
  6. バージョン間の互換性の問題(Excel97以前のデータの非互換性)
  7. マクロウィルス感染の危険性
  8. 電子署名が使用できない
  9. 作成や修正の都度、必ず手作業を伴う
  10. 目次、インデックス等の自動生成ができない

特に1.と2.においてFDAの21 CFR Part 11や厚労省のER/ES指針の遵守において問題となる。
またそれ以外においては、データインテグリティの問題がある。
つまり故意ではないデータのミスが生じる可能性がある。

一般に電子で記録を作成し、紙媒体に印刷した上で手書き署名を付した場合(ハイブリッド運用)、データの信頼性に欠くことになる。
ハイブリッド運用では、後になってから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ができるためである。

FDAの査察官は、データ不正の手口とその発見方法を教育されている。
例えば、手書き署名の日付よりもExcelのファイル日付が新しい場合、何が疑われるだろうか。(図参照)

この図の場合、2016年8月22日に記録を修正(改ざん)し、2015年3月31日付で署名(バックデート)したことが疑われる。

Excelにより記録を作成する場合には、以下を保証する必要がある。

  • Excelのファイル日付と紙媒体上の署名日付が一致していること
  • Excelの内容と紙媒体の内容が一致していること

上記のいずれかを満たさない場合、改ざんが疑われ、また改ざんをしていない証拠を提示することが困難となる。

そこでExcelを使用しデータを入力した場合の留意点は以下のとおりである。

  • 入力後、すみやかに印刷し、当日の日付で署名すること。(pdf化し、電子署名を付しても構わない。)
  • 入力したExcelは、削除しないこと。
  • 入力したExcelは、タイムスタンプ(ファイル日付)を変更しないこと。
  • 入力したExcelは、セキュリティで保護された環境で管理すること。(CD-R等に焼くのがベスト)

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