電子署名は、電子文書の正当性を保証するために付けられる署名情報のことです。
紙の書面には捺印ができますが、電子文書には捺印ができないため、電子署名を捺印に相当すると法的に認めたものです。
電子署名は、文字や記号、マークなどを電子的に表現して署名行為を行なうこと全般を指します。
特に、公開鍵暗号方式を応用して、文書の作成者を証明し、かつその文書が改ざんされていないことを保証する署名方式のことを「デジタル署名」と言います。
電子署名は、以下の２つ要件に該当しなければなりません。
1.当該情報が当該措置を行った者の作成に係るものであることを示すためのものであること。（本人性証明）
2.当該情報について改変が行われていないかどうかを確認することができるものであること。（非改ざん性証明）
多くの人が誤解しているのが「21 CFR Part11と日本版ER/ES指針の電子署名は同じだ。」ということです。
実は日本版ER/ES指針の電子署名とPart11の電子署名は異なります。
日本版ER/ES指針では、4.(1)で「電子署名及び認証業務に関する法律(平成12年5月31日法律第102号)に基づき、電子署名の管理・運用に係る手順が文書化されてお、適切に実施していること。」と記載されており、電子署名法でいう電子署名と定義が同じであることがわかります。
一方、Part11では、ユーザIDとパスワードの組合せまたはバイオメトリックスにより、真の所有者のみが行える行為を電子署名と定義しています。
この方法では、上述した2つの要件のうち1.の「本人性証明」のみを満たすことになります。
つまりPart11の定義する電子署名では、2.「非改ざん性証明」ができません。
通常、電子署名を伴う電子文書を保存する場合は、pdfフォーマットを利用します。
なぜならばpdfでは電子署名を同一ファイルに埋め込むことができ、送信などの際にリンクが切れないからです。
現在のところMS-Word等では、電子署名を埋め込むことができないことから、リンクが切れないという保証が困難です。
電子署名は、認証局（CA）による電子証明書を伴わない場合、当該情報が当該措置を行った者の作成に係るものであること証明することができません。（主張することはできます。）
また第三者による改変の事実は発見できるが、本人による改変は見抜けません。（この場合第三者によるタイムスタンプが必要となります。）
先に述べましたように、電子署名は紙社会における印鑑に相当します。
紙社会においても、書面の重要性に応じて、三文判でも良いのか、実印が必要なのかが決まります。
電子の世界でも同様のことが言えます。
電子文書の重要性に応じて、認証局（CA）の認証（電子証明書）を伴う電子署名（つまり実印に相当する）を利用するのか、電子証明書を伴わない電子署名（つまり三文判に相当する）で済ませるのかを判断しなければなりません。
当然のことながら副作用の電子報告に見られるように、規制当局がCAの認証を伴う電子署名を求めている場合は、それに従わなければなりません。
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・【超入門】厚労省ER/ES指針、21 CFR Part 11対応セミナー
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