米国では、80年代に医療機器のソフトウェアの不具合により、患者の死傷事故が発生しました。
それ以降、FDAはヘルスケア企業が製造する製品だけではなく、使用するソフトウェアに関しても品質保証を行うことを求めてきまし。
つまりシステムの開発･導入時においてもIndependentなQA部門が品質保証を行うことを要求しているのです。
これが現在のCSVの元になる考え方です。
日本ではこういう考え方はまだ浸透していません。
多くの企業におけるQAは業務プロセスに注力していて、システムのQAを実施できる部門やスキルを持った人の養成が遅れています。
さて、それではシステムの信頼性保証はどうあるべきでしょうか。
例えばバリデションマスタープランの承認、PQ計画書・報告書の承認、バリデーション報告書の承認など、プロジェクト期間中のオンゴーイングなレビュや助言がそれに相当します。
その際に重要なことは、文書中の誤字や整合性を指摘するのではなく、第三者による再現性を判定することです。
バリデーションチームによって作業が行われている記録や文書を照査し、もし自分が行ったとしても同様の結果や判定が得られただろうかという点を検討しなければなりません。
再現性というのは「たまたまやったらたまたまうまくいきました。」というような偶然性ではないこと－つまり誰がやっても同じ品質結果（基準）が得られるということを第三者的に保証することです。
牛肉などで有名になった「トレーサビリティ」は信頼性保証の最低限の要求事項です。
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