筆者はしばしばFDA査察に立会うことがある。
その際に査察を受ける企業から、「FDA査察において原本を提示しなければならないか。」といった質問を多く受ける。
答えはNOである。
質問者の意図は、SOPや記録の原本（つまり署名や捺印したもの）は紙媒体であるが、電子版をスクリーンで投影した場合、サインのないものになってしまうという懸念である。
多くの場合は文書（SOP）や記録は電子で作成され、印刷した後に署名または捺印をしている。
したがって、ドキュメント管理システムやデータベースに保存されている電子記録には署名や捺印がないのである。
筆者が多くFDA査察に立会った経験では、原本であるかないかを問われたことは一度もない。
FDA査察において肝心なことは、要求された資料を素早く提示することである。
紙媒体を検索して提出するまでにFDA査察官を待たせるよりは、素早く電子で提示した方がはるかにFDA査察官の心証は良い。
万が一、原本の提示を求められた際には時間がかかることを断ったうえで、検索し手提示すれば良いだろう。
しかしながら、コピーの提供（つまり査察官が持ち帰る）を求められた場合には、必ず捺印または署名されたもののコピーを作成しなければならないので留意が必要である。
捺印と署名は何が異なるか？
またしばしば、「捺印を手書き署名に変更した方が良いか。」といった質問を受ける。
回答は出来る限り手書き署名にした方が良いであろう。
査察や監査においては、相手国の法律や慣習を尊重しなければならないといった暗黙のルールがある。
FDA査察官は、けっして捺印が好ましいとは思っていない。
なぜならば他人が捺印できる（すなわちなりすまし）からである。
手書き署名には優れた利点がある。
それはコピーをとってもスキャンしても原本と同等と考えられるというものである。
なぜならば、書体（筆記体）自体が本人性を証明するからである。
私事ではあるが、筆者は外資系企業に長年勤務していた。
その際に、上司のサインをFAXでもらっていたことを記憶している。
また現在でも外国の企業との契約は署名したものをスキャン（pdf化）し、先方に電子メールで送付し、先方が署名したものをスキャンしたものを電子メールで送り返してもらっている。
これで契約が成立している。紙原本は必要ない。
また、捺印の場合、例えば代表取締役社長が田中さんから鈴木さんに変更になっても、印鑑自体は変更しない。
しかしながら、署名の場合は、必ず変更しなければならない。
何故ならば署名は個人に特有であるからである。
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