コロナウィルス禍のもと、多くの企業がテレワークに移行している。
しかしながら、本邦の場合、捺印(押印)をするためだけにリスクを冒して公共交通機関で出勤しなければならないといった問題点を耳にする。
私事ながら、筆者は外資系企業しか勤務したことがなく、役所関係の文書を除いては、社内において捺印といった文化にはほとんど触れてこなかった。
手書き署名の利点は、FAXやスキャンしても本人性を証明できることである。なぜならば筆跡が本人を特定するためである。
承認などの際にFAXで署名を返送すれば良い訳である。
一方で印鑑は誰が捺印したかは特定できない。他人が成り代わって捺印するといったいわゆる「なりすまし」が容易に行える訳である。
電子署名に関しては、米国FDAによる21 CFR Part 11や、厚労省のER/ES指針などが規制をかけている。
しかしである。
Part 11やER/ES指針は、手書きの署名を電子化する際の要件である。
決して、印鑑を電子化するための要件ではない。
上述の通り、手書き署名は本人しかできない。しかしながら、電子署名には”筆跡”がないため、だれでもが”なりすまし”ができるのである。
そこで、電子署名に、手書き署名と同等の要件を持たせたものがPart 11やER/ES指針である。
通常、印鑑(デート印を含む)を用いて承認している書面があったとしよう。
これを電子化する際にはPart 11やER/ES指針に従わなければならないというのは、いわば理不尽ではないだろうか。
印鑑においても本人性を証明できないのであるから、電子化した際にも同等でなければならないのであれば、電子印鑑が認められなければならないのではないだろうか。
規制要件では、印鑑に関する是非は要件に記載されていない。
本来は、GxP関連の文書、記録は印鑑を廃止し、手書き署名にするべきである。そうでなければ紙の記録等の真正性の証明ができない。
でなければ本邦においては電子印鑑も認められなければならないのではないだろうか。
ER/ES指針は単純にPart 11を参考に(似せて)制定された。しかしながら、印鑑および電子印鑑に関して要件(それらの管理要件等)を盛り込んでいないのは不完全であると筆者は常々考えている。
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