クローズドシステムとオープンシステム

21 CFR Part11やER/ES指針において、クローズドシステムとオープンシステムという用語が定義されている。
筆者はそれらの違いについて正しく理解されていないケースが多いと感じている。

21 CFR Part11では、クローズドシステムとオープンシステムの定義は以下のとおりである。

クローズドシステム
クローズドシステムとは、システム上の電子記録の内容に責任を有する人がシステムへのアクセスを管理する環境を意味する。
オープンシステム
オープンシステムとは、システム上の電子記録の内容に責任を有する人がシステムへのアクセスを管理することはしない環境を意味する。

これではさっぱり意味が分からない。
クローズドシステムとは、社内にあるコンピュータシステムであり、それらがLANで接続されている状態を含む。
オープンシステムとは、インターネットを介した通信を扱うシステムのことである。

通常はオープンシステムは存在しない。
社内にあるクローズドシステムと、別の場所にあるクローズドシステムをインターネットで接続した際にオープンシステムが出現するのである。
例えば、自宅のPCとAmazonや楽天のサーバーを接続した際にオープンシステムとなるのである。

オープンシステムは、ネットワーク上に自社(自身)では管理できないサーバが存在する。
そのため、インターネットには盗聴、改ざん、なりすましといったリスクがあり得るのである。
これらのリスクを回避するために、オープンシステムでは通信の暗号化とデジタル署名の利用を要求している。
具体的には、SSL(Secure Socket Layer)を使用すれば上記の要件を満たすことになる。

最近、インターネットにおけるすべての通信はSSL化が要求される時代となった。
2018年10月初旬までに、常時SSL対応をしていないサイトは、ほぼ全てのブラウザで「保護されていない通信」である旨の警告が出るようになる予定である。

イーコンプライアンスでは、【超入門】コンピュータバリデーション & ER/ES指針セミナーのVOD配信及びビデオ販売を行っております。

【超入門】コンピュータバリデーション & ER/ES指針セミナー
【セミナービデオ】【超入門】コンピュータバリデーション & ER/ES指針

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