これまでに何度も指摘を行ってきましたが、たとえ紙で承認を行ったとしても、当該電子記録は削除してはいけません。
何故ならば、紙の上には監査証跡がないからです。
ところが、電子記録を長期間維持することはたやすいことではありません。
コンピュータシステムは、定期的にリプレースされます。
通常旧システムから、新システムに移行する際には、データの移行を行います。
しかしながら、監査証跡を移行するケースはほとんどないのではないでしょうか。
監査証跡のない電子記録は、査察に耐えることができません。
FDAは、監査証跡が消去されている場合などは、査察を拒否します。
またワーニングレターを発行することがあります。
FDAは、1994年にPart11のドラフトを発行した際には、本物を保管しておくように要請していました。
つまり査察を行うまで、旧システムを維持することを求めたわけです。
しかしながら、この要求について、製薬会社は反発しました。
旧システムを査察のためだけに温存しておくことは不合理です。
故障のリスクやメンテナンスの費用、さらにライセンス料も負担し続けなければなりません。
このことをパブリックコメントで指摘され、FDAは1997年にPart11のファイナルルールを発行した際には「正確かつ完全なコピー」を実施することと要求を変更しました。
つまり、旧システムから新システムに、監査証跡を含めて正確にかつ完全に移行しなければならないということです。
しかしながら、これにも問題があります。
同じメーカの同じソフトウェアのリプレースであれば可能でしょうが、メーカが違う場合にはほとんど不可能でしょう。
ちなみに、査察が行われるまでの間、旧システムを温存する方法を「タイムカプセルアプローチ」と呼びます。
また旧システムから新システムに移行する方法を「マイグレーションアプローチ」と呼びます。
電子記録を保持するために、タイムカプセルアプローチをとっても、マイグレーションアプローチをとっても、問題があるわけです。
つまり紙の記録と違って、電子記録を長期間保持し続けることは困難であるわけです。
では、米国の製薬企業は一体どんな方法で、この問題を解決したのでしょうか。
それはデータベースのみの保持です。
査察時に必要なことは、電子記録の検索のみです。
つまり査察時に検索が容易であればFDAも問題ありません。
システムをリプレースする際に、旧システムは廃棄しますが、データベースのみは温存します。
その上で、SQL文を作成し、査察官が電子記録を検索するツールを用意しておけば良いわけです。
データベースもバージョンが上がることがありますので、それに合わせてアップグレードして行けば良いわけです。
ただし、データベースの構造や、データを変更してはいけません。
検索ツールも、データを変更できるものであってはいけません。
くれぐれもシステムを買い替える際などには、まず現在保持している
電子記録をどう保持し続けるかを検討することが大切です。
安易にシステムを廃棄してはなりません。
システム廃棄計画書を作成し、電子記録の保持方法について十分な検
討を行っておく必要があります。
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