バリデーション報告書の目的

各社でCSVドキュメントのレビュ依頼を受けることが多くあります。
その中でよくコメントするのは「バリデーション報告書」の書き方です。
何社かで経験したのは「バリデーション計画書」と「バリデーション報告書」がほぼ同じ内容になっているということです。
つまり、Cut & Pasteをして「~をする」を「~をした」に変更しているのでしょう。
「計画」と「結果」が一致するというのは、実は奇妙です。
「バリデーション報告書」を執筆する際に必要なのは、「計画」からの逸脱を記載することです。
つまり、計画通り実施できた事項に関してはあまり記載の必要がなく、むしろ計画通り実施できなかったことを「正当化できる理由」と共に記載しなければなりません。
バリデーション期間中の障害や、変更のサマリーとそれらによるインパクト(リスク)を十分評価し、たとえ障害や変更があったとしてもサービスインしてもかまわないという理由(または回避すべき事項)を検討してください。

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