ファイルとは 

ファイルとは

医療機器規制においてファイルという用語がしばしば登場する。
例えば、設計履歴ファイル(DHF:Design History File)、リスクマネジメントファイル(RMF:Risk Management File)、ユーザビリティエンジニアリングファイル(UEF:Usability Engineering File)や苦情ファイル(21 CFR Part 820 §198)などである。
では、ファイルは何のために必要なのであろうか。
ファイルは、査察官や第三者認証機関の監査員が、規制要件や国際規格の要求事項に従って、調査しやすいようにまとめておくものである。
例えば、医療機器設計のうち、リスクマネジメントに関する事項はリスクマネジメントファイルにまとめておかなければならない。
査察官や監査員は、当該ファイルを調査すれば、該当する規制要件や国際規格の要求事項を遵守した活動が実施され、記録が適切であるかどうかを素早く確認することが出来るのである。
したがって、ファイルは各国際規格などの適合性の確認のために使用されるものである。

ただし、ファイルには包含関係が存在する。
DHFの中にRMFが包含され、RMFの中にUEFが包含される。
またファイルは物理的なバインダーを作成し、物理的に文書を綴じ込むものではない。
いわば、各記録へのリンクを示したものであり、インデックスである。
例えば、設計文書中には、リスクマネジメントに関する記載もあり、またユーザビリティエンジニアリングに関する記載もあると思われる。
RMFやUEFなどからは、当該設計文書の記載されている章番号等をポイントするのである。

関連商品

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