CSV実施に関する質問

先日実施したCSV(Computerized System Validation)セミナーで、以下のような質問を受けた。
同様の疑問を持っている方のために筆者の回答をシェアしたい。

【質問1】
CSVの文書は、すでに導入されている電子機器等にも追加で作成しなくてはならないのでしょうか?

【回答1】 
その通りです。
CSVのみならず品質保証は、あくまでも患者・ユーザの安全性を確保するために実施する必要があります。
従って、過去に導入した電子機器とは言え、患者・ユーザの安全性確保のためにCSVを実施する必要はあります。

ただし、例えばすでに3年以上使用しており、問題が起きていなければ、新規導入時と同じようなCSVを実施する必要はありません。
実績で安全性や不具合がないことを証明しているからです。
この場合は、運用の記録(変更記録・障害対応記録)等を残しておいてください。
その場合においても、ユーザ要求仕様書、バリデーション計画書、リスク評価報告書、バリデーション報告書等は作成が必須です。
特にユーザ要求仕様書は必須です。CSVはシステムの仕様がユーザの意図した利用に適合していることを確認するためだからです。
バリデーション計画書には、システムの仕様がユーザの意図した利用に適合していることを過去の実績から確認する旨の計画を記載してください。
バリデーション報告書には、過去の実績から品質(=ユーザの意図した利用に適合していること)、品質保証、リスク管理に問題がない旨を簡潔に記載してください。

ただし、リスク評価報告書においてリスクが高いと評価された場合は、完全なCSVを再実施してください。(リスクベースドアプローチ)

【質問2】
「リスクが低いと判断できたものは、やる必要がない。日本人は挙がったものすべてやりがち」というお話がありましたが、何か、やりすぎていると思われた事例がありましたら、例を教えていただけませんでしょうか。いつも、やらなくてもいいという判断を出しかねています。

【回答2】
これはシステムテストのご質問ですね。(規制要件対象のシステムは、リスクの高低に関わらずCSV実施は必須です。ただし、実施レベルが異なります。)
やり過ぎの例は、WindowsなどのOS、パソコン本体、分析機器のような出来合いのシステム(製品)のテストでしょう。
テストする必要はありません。メーカーが保証しているからです。
CSVの目的はあくまでもシステムの仕様がユーザの意図した利用に適合していることを確認することです。
貴社のSOPに従って業務が遂行できれば問題がないわけですので、それが証明できる程度のテストを実施すれば良いです。

また教育記録システムも同様です。教育記録は規制を受けますが、例えデータが狂ったとしても患者・ユーザに危害は生じません。
さらに文書管理システムです。文書管理システムにバグがあっても保存してある文書は変更されません。
あくまでも業務上差支えがないことのみを確認してください。

【質問3】

弊社ではエクセルを使用した品質記録が多くみられます。
例えばVLOOKUP等の関数を使用して、製品番号を基に販売名を抽出するというような製造指図書がある場合、この関数が正しく機能することの確認をとり、記録に残す必要があるのでしょうか。
あるいは市販のアプリなのでそこまでは求められていないのでしょうか。

【回答3】
CSVはバグを潰すために実施するわけではありません。
従って、VLOOKUP機能そのものをテストし、記録を残す必要はありません。
しかしながら、当該製造仕様書が”正しく”作成されることをテストし、記録を残しておくことは必要です。
つまり「手作業で実施していたことと、電子化して実施したことが同じ結果になる」ことを証明する必要があります。

【超入門】コンピュータバリデーション & ER/ES指針セミナー
【中級編】コンピュータバリデーションセミナー

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