医療機器企業が実施しなければならないソフトウェアバリデーション について
FDAガイダンス「General Principles of Software Validation」において医療機器企業がソフトウェア のバリデーション を実施しなければならないものとして以下の4種類があげられている。
これらのうち上の2つは設計バリデーション の対象となり、下2つはCSV（Computerrized System Validation）の対象である。
医療機器企業におけるソフトウェア バリデーション 規制要件
FDAが査察を行う理由はただ一つである。それは、粗悪な医療機器の米国輸出を阻止 し、米国における患者・ユーザを保護することである。
昨今の医療機器では、ソフトウェア が搭載されていることが多い。 海外では、医療機器に搭載するソフトウェア の開発には、非常に厳格な規制要件の 遵守が義務付けられている。
IEC62304「Medical device software – Software life cycle processes」やFDAガイダンス「General Principles of Software Validation」等に対応しなければ海外展開できない。
ソフトウェア を搭載した医療機器の海外展開に際しては、IEC62304に準拠してソフトウェアを設計開発することが必須だ。
つまり、医療機器企業は、IEC62304に準拠したソフトウェア の開発プロセスを構築 しなければならない。
IEC62304には、ライフサイクルプロセスの規格が概説され、ソフトウェア 品質を確保するための製造者のアクティビティについて規定されている。
しかしながら、これまで国内向け医療機器製品は、IEC62304などの海外規格を意識せずに開発をしていることが多いと思われる。
なぜならば、日本においては、これまでは医療機器ソフトウェア 開発に関する規制がなかったからである。
2014年、薬事法が一部改正された。これまでの「薬事法」という名称から、「医薬品、医療機器等の品質 、有効性及び安全 性の確保等に関する法律」（略称：薬機法）という名称に変更されることとなった。
医薬品医療機器等法では、医療機器の「機械器具等」の範疇に、「ソフトウェア （プログラム）」が追加された。
具体的な要件は、今後の厚生労働省からの規制要件発出を待たなければならない。
米国では、1985年から1987年にかけて、放射線治療装置のソフトウェアのバグにより、6名の犠牲者が出るといった事故が発生した。
この事故を受けて、FDAは1987年に『General Principles of Software Validation』 （GPSV）を発行した。
米国に輸出するためには、GPSVにも準拠しなければならない。
また、たとえIEC62304の適合認証を受けていたにもかかわらず、FDAから厳しい指摘を受けることもある。
GPSVでは「医療機器ソフトウェア の妥当性確認または医療機器の設計、開発、製造 に使用されるソフトウェア の妥当性確認に適用可能であると食品医薬品局（FDA）が 考える、バリデーション に関する一般原則」の概要を示している。
これらの原則は以下のソフトウェア に適用される。
・ 医療機器のコンポーネント、パーツ、又はアクセサリーとして用いられるソフトウェア
・ 医療機器であるソフトウェア （例：血液組織ソフトウェア ）
・ 装置の製造に用いられるソフトウェア （例：製造機器内のPLC）
・ 機器製造業者用品質 システムの履行に用いられるソフトウェア （例：機器の履歴 を記録、メンテナンスするソフトウェア ）
ただし、FDA は特定の開発・バリデーション に関する手法には言及していない。
FDA による主なガイダンスとして、
・ Guidance for the Submission Of Pre-market Notifications for Medical Image Management Devices （医療画像処理機器の市販前通知申請に関するガイダンス）
・ Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices (医療機器に含まれるソフトウェア の市販前申請に関するガイダンス)
・ General Principles of Software Validation; Final Guidance for Industry and FDAStaff（ソフトウェア バリデーション の一般原則）
・ Off-The-Shelf Software Use in Medical Devices （医療機器における市販ソフトを利用）
などがあり、また規制要件や業界標準は常に更新されるため、必要な規則を全て遵守することは容易ではない。 今後IEC62304は、IEC82304、IEC80001の発行と相まって、改訂が予定されている。
関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
・医療機器企業におけるCSV実践セミナー
セミナービデオ
・医療機器企業におけるCSV実践セミナー
・医療機器企業における設計管理・リスクマネジメント・バリデーションセミナー ～バリデーション編～
QMS（手順書等）ひな形販売
・ 【2021年度改正QMS省令対応】ソフトウェアバリデーション規程・手順書
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