筆者は多くの医療機器企業でコンサルテーションを実施してきた。
その際に「このソフトウェアは、カテゴリ4ですか？」などと質問を受けることがある。
この質問には、非常に違和感を覚える。
カテゴリ分類は、製薬業界の自主基準ともいえるGAMPの方法論である。
GAMPはもともと、製剤工場の自動化工程の品質保証のために作成された。
カテゴリ分類は、「構造設備」に搭載されたソフトウェアを分類する際には有効である。
そもそも、GAMPは医療機器企業のソフトウェア開発には向かない。
医療機器企業を対象としたどの規制要件にも、GAMPを参照せよとは記載されていないのである。
どうして医療機器企業でGAMPが使用され始めたのかは定かではない。
本邦においては、医療機器企業に対するソフトウェアの設計管理に関する規制要件は存在しない。
しかしながら、米国FDAは1985-1987年に放射線治療装置のソフトウェアの不具合により6名の人命が失われた事故を教訓として、
General Principles of Software Validation（GPSV）が発行した。
GPSVは、1987年に初版が発行され、2002年1月にファイナルガイダンスとして発行された。
GPSV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バリデーションの原則を記述したものである。
また、医療機器にかかわる業界およびFDAのスタッフに対するCSV関連の指針となっている。
ソフトウエア開発において実施すべき一連の検証プロセスを詳細に規定している。
GPSV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）
今年改正される薬事法（「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」と改称）では、
医療機器に搭載するソフトウェアの品質保証が強化される。
一方で、欧州、カナダ、豪州などでは、医療機器に搭載するソフトウェアとソフトウェア単体の医療機器に関しては、
IEC-62304を遵守しなければならない。
つまり、IEC-62304、FDAガイダンス（GPSV）に対応しなければ海外展開できないのである。
医療機器企業は、GAMPではなく、GPSVやIEC-62304に準拠したソフトウェア開発およびバリデーションを実施しなけらばならない。
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