筆者がCSVセミナーをする中で、あまりにもカテゴリ分類にこだわっている人が多いのには辟易する。
規制当局が定義する「バリデーション」とは、当該システムがユーザ要求に完全に一致している状態をいう。
つまり、パッケージシステムを導入する場合、構成設定やカスタマイズを実施して、ユーザが要求する機能を実現するのである。
GAMPでは、ソフトウェアのカテゴリを5段階に分類している。
パッケージシステムの機能が、そのままでユーザ要求を満たしている場合、カテゴリは3である。
またパッケージシステムの機能を構成設定(コンフィグレーション)して、ユーザ要求に合わせた場合、カテゴリは4である。
さらにパッケージシステムの機能をカスタマイズして、ユーザ要求に合わせた場合、カテゴリは5である。
いずれの場合も、その目的は、ユーザ要求にシステムを合せることであって、カテゴリを分類することではない。
筆者はよく次のような質問を受ける。
「このシステムを何とかカテゴリ3と判定できないか。」
「パッケージの一部分でもカスタマイズしたら、カテゴリ5になるのか。」
これらの質問は、本末転倒である。
カテゴリ分類することが目的やゴールになっているとすら思えてくる。
コンピュータシステムにとって大切なことは、ユーザ要求を完全に満たし、患者の安全性、製品の品質、電子データの完全性を保証することである。
つまり、リスクに対して適切にシステムの品質保証を実施しなければならない。
したがって、カテゴリ3であっても、リスクの高いシステムがあり、逆にカテゴリ5でもリスクの低いシステムはある。
カテゴリ分類は、構造設備(プロセスコントロール)には有効的てあったが、ITアプリケーションではほとんど意味をなさない。
なぜならば、ITアプリケーションでは、カテゴリ3、4、5が混在してしまうからである。
厚労省が平成24年から施行した「コンピュータ化システム適正管理ガイドライン」では、カテゴリ分類が大きく取り上げられているが、その罪は重い。
そもそも、FDAやEMAのソフトウェアバリデーションに関する規制要件では、カテゴリ分類などはない。
ソフトウェアに限らず、製薬企業・医療機器企業で使用するシステムは、リスク(患者・ユーザに対する安全性、製品品質に対する影響等)に応じてその品質管理・品質保証の程度を決定するべきである。
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