品質イベント管理システムとは

品質イベント管理システムとは

品質イベント管理システムとは、顧客苦情管理、不適合管理、変更管理、工程変更管理(4M変更)、内部監査管理、教育管理、CAPA管理等を支援するシステムのことです。 品質イベント管理システムは、ドキュメント管理システム(EDMS)と同時に導入することによって、よりFDA査察対応能力を増強させることができます。 ドキュメント管理システムは、QMS、DHF、DMR、DHR、MDR、QSR(品質記録)等を電子的に一元管理するシステムのことです。 ドキュメント管理システムでは、電子ワークフローを構築することが一般的です。

医療機器企業各社の課題・問題

品質イベント管理システムとは

「イベント管理システム」および「ドキュメント管理システム」はFDA査察対応の要です。

品質イベント管理システム

医療機器企業のFDA規制要件に対応できるイベント管理システムとして著名なパッケージシステムには、以下の2つがあります。 1.TrackWise(Sparta Systems社) 2.MasterControl (MasterControl 社) いずれも比較的大規模なシステムで、高価です。 またシステムそのものは、電子ワークフローシステムですので、ユーザ要件に従って構築する必要があります。 両システムともドキュメント管理機能を備えていますが、イベント関連以外のドキュメントとのリンク等を考慮した場合、別途ドキュメント管理システムを導入する企業が多いです。 いずれにせよ、貴社でFDA規制要件対応要求事項を明らかにし、当該ベンダーにユーザ要求仕様書を提供する必要があります。

ドキュメント管理システム

ドキュメント管理システムでは、まず社内のQMSを管理する必要があります。 QMS管理は、作成、改訂、発行、廃棄をそれぞれ管理できるものでなければなりません。 FDA査察対応時には、(過去に廃棄したものを含めて)適切なQMSを検索し、提示できる必要があります。 また、業務遂行によって作成された各記録を適切に管理できなければなりません。 一般に市販されているドキュメント管理システムは、安価なものから高価なものまで様々です。 貴社のQSR対応の場合、あまり高価なシステムを導入する必要性はありません。 いずれにせよ、貴社でFDA規制要件対応要求事項を明らかにし、当該ベンダーにユーザ要求仕様書を提供する必要があります。

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