そもそもURSではCSVの作法を気にすることなく、ユーザの「思いの丈」を記載すればいいと思っています。
システム担当者は、いわばそのユーザの「思いの丈」をシステムで実現するのが仕事です。
これまでも解説を行ってきましたとおり、ICHなどの定義によると、バリデーションの定義はこうです。
「電子データ処理システムが、完全性、正確性、信頼性及び意図された性能についての利用者の要件を満たしていることを保証し、文書化すること。」
つまりバリデーションのゴールのひとつは、利用者(ユーザ)の要求(=URS)をシステムが満たすことです。
ここでいう”性能”とは英語に訳すと”Performance”です。
PQ(Perfomance Qualification)の目的は、このユーザが要求する性能(Perfomance)をシステムが出せるかどうかを検証(Qualification)することです。
ただし誤解していけないのは、ここでいうPerfomanceは、コンピュータの性能ではなく、業務が遂行できる能力と解釈しなければなりません。
このように、URSはPQの元になります。
したがってURSに記載するユーザの要件は箇条書きにし、それぞれが識別できるように個別のIDを付与する必要があります。
そうしなければ、URSとPQとのトレーサビリティ・マトリックスが書けないことになります。
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