ソフトウェアに関するワーニングレター

イーコンプライアンス　ソフトウェアバリデーションに関するワーニングレター

＊万が一文中に解釈の間違い等がありましても、当社では責任をとりかねます。
　本文書の改訂は予告なく行われることがあります。

SAN UP S.A.（2013年11月25日）

コンピュータ・ソフトウエアがバリデートできていない

医療機器製造をバリデートするコンピュータがバリデーションできていない

21 CFR 820.70(i)に要求されるとおりに、既定プロトコールに従った意図する使用に対してコンピュータ・ソフトウエアがバリデートできていない。

例えば、貴社は標準作業手順書、フォームおよび他の記録を作成し、保管し、広めるために【redacted】を使用している。貴社はまた、機器履歴簿(DHR)および他の品質システムデータの作成、保管のためにも【redacted】を使用している。
査察の間、貴社は、貴社の製造機器に用いられているソフトウエアはないため、2011年3月14日付の“Validacion del software utilizado en el sistema de calidad, GC-E-07-49, Rev. 00,”の手順は、バリデーションは品質システムに使用されるソフトウエアおよびドキュメントに重点を置いていると説明した。
しかしながら、貴社は、ソフトウエア・プログラムが意図する使用に対してバリデートされていることを実証するいかなるエビデンスも作成していなかった。

Trokamed GmbH（2013年11月22日）

コンピュータ・ソフトウエアがバリデートできていない

21 CFR 820.70(i)に要求されるとおりに、コンピュータあるいは自動データ処理システムが、生産または品質システムの一部として使用される場合、既定プロトコールに従った意図する使用に対し、コンピュータ・ソフトウエアのバリデートができていない。
例えば、CAPA2335の一環として開発された2013年3月25日付ドキュメント番号No. IN-26_01_002, No. 1 Validierungsmasterplan [Validation Master Plan]が記載するには、【redacted】、【redacted】、【redacted】は、クリティカルとみなされるソフトウエア・プログラムであり、それゆえソフトウエアバリデーションが必要である。
貴社はこれらのプログラムをバリデートしていない。

21 CFR 820.40に要求される通りに、21 CFR 820により要求されるすべてのドキュメントを管理する手順書の確立と維持ができていない。
例えば、品質マネージャ／品質責任者は、CAPA 1716 および CAPA 2339のすべてのアクションを2013年3月30日まで、および2011年7月11日までにそれぞれ完了したと述べているけれども、2013年6月23日まで【redacted】ソフトウエアシステムは最終化されていなかった。

加えて、2011年2月23日付のテストレポートの2011-02-23_UBの管理されていない印刷（ハードコピー）が、2013年6月の査察中にR&Dマネージャによって新たに作られていた。

それは承認の署名がなかったからであった。

Jabones Pardo S.A. （2013年8月22日）

バリデーションプログラムが確立できていない

医薬品製造設計がバリデートできていない

貴社は　原料、バルクおよびテストリリースを終了した製品の生産、在庫、ロット番号付け、臨床試験方法に使用するコンピュータ・ソフトウエアMicrosoft Dynamicsのプログラムバリデーションを確立していなかった。
貴社はまた、生産、文書化およびコンポーネントの管理する品質ユニットを支援するためにもMicrosoft Dynamicsのプログラムを使用している。

Apnea Sciences Inc （2013年5月9日）

CAPA手順がない

不十分なコンピュータシステム／CAPAの手順漏れ・手順なし

これらの違反は以下を含むが、それらに限定されない。

1. 21 CFR 820.100(a) に要求されるとおりに、是正・予防措置をインプリメントする十分な手順書が確立および維持できておらず、21 CFR 820.100におけるすべてのアクティヴィティが文書化できていない。

例えば、2012年10月9日付の貴社の品質マニュアル、Rev. A, Section 8.4において、貴社は苦情、内部監査、サプライヤパフォーマンスおよび不適合材料の品質データを文書化し、分析する手順書を確立していると述べている。
Section 8.5では、再発を防ぐために不適合の原因を除去する是正・予防措置（CAPA）プログラムをインプリメントしたと述べている。
しかしながら、貴社には文書化されたCAPA手順書がない。加えて、貴社には、CAPAアクションの必要性を決定するための、苦情、内部監査、サプライヤパフォーマンスおよび不適合材料等のソースを通して得た品質システムデータの分析記録がない。

貴社の返信文には、より詳細に定義したCAPAポリシーおよび手順を90日以内に実施すると書かれてある。
貴社の返信は十分でない。

Wockhardt Limited （2013年7月18日）

通常のPCアクセスにより生データファイルが削除されている

製薬メーカーのコンピュータシステム

加えて、貴社の品質管理HPLC生データファイルは、通常のPCログインしたすべての【redacted】分析者によって、ハードドライブから削除することができる。
この削除は、サンプル注射および分析の記録をすべて除去する。
貴社は、この削除機能は一部の【redacted】HPLC機器に使用されているソフトウエアにのみ利用可能であると回答している。貴社はまた、「ユーザ」権限の研究所の分析員がファイルを削除あるいは名前を変更できないようにアクセスコントロール特権を変更したと述べている。

また、当局は2013年3月20日に、貴社の品質管理分析者が、査察官に「他のサンプル」を使用して【redacted】注射、USP（【redacted】mg/ml）のテスト方法を完了したと述べていることに着目している。

Intuitive Surgical, Inc.　（2013年7月16日）

CAPA非実施

コンピュータシステム医療機器製造

査察によって明らかになったことは、貴社のダビンチシステム　IS1000、IS1200、IS2000、IS3000、チップ・カバー・アクセサリー及びカニューレ8mmレギュラーが、the Act, 21 U.S.C. 352(t)(2) のsection 502(t)(2) において、機器の商標表示が誤っていることである。
それは、Act, 21 U.S.C. § 360i及び 21 CFR 806-Medical Devices： Reports of Corrections and Removals regulationにおいて要求される機器に関し、材料あるいは情報を提供できなかったあるいは拒否したことである。

重大な逸脱は下記を含むがそれらに限定されない。

機器によりもたらされる健康へのリスクを減らし、あるいは21 CFR 806.10(b)により要求される健康へのリスクを示した法への逸脱を処方するために修正あるいは除去が開始された場合、是正あるいはデバイスの除去から10営業日内にFDAに文書報告を提出しなかった。

これらの不履行の例は、下記に含むがそれらに限定されない。

1.2011年10月、Intuitive Surgical, Incは、ダビンチ医療システムのクライアントに、チップ・カバー・アクセサリーおよび単極装置と一緒に使用する発電装置を適正に使用する提案および提言文書を送り、改修を開始した。この改修は、患者に被害を与えた異常チップ・カバーの放電に対する苦情及びMDRに対応するものであった。当該機器により起きた健康へのリスクを減らすためにこの改修が講じられたけれども、貴社はFDAが要求するとおりに改修を報告することができなかった。2013年4月19日の貴社のリコール報告は、FDAによりClass II recall, Z-1425-2013と分類された。

Techlem Medical Corporation （2013年7月5日）

医療機器会社においてコンピュータ・ソフトウエアをバリデーションできていない

医療機器製造会社におけるコンピュータ・システムのソフトウエアをバリデートできていない

機械化され、自動化され、あるいは電子的な検査及びテスト装置を含む、全ての検査、測定及びテスト装置が、21 CFR 820.72(a) に要求される通りに、その意図する使用に適しており、有効な結果をもたらすことができるという保証ができなかった。

例えば、貴社の設計ベリフィケーション手順は、使用に先立ち設計ベリフィケーション・アクティビティの利用に先立って必要とされる、テスト装置及びソフトウエアが十分にバリデートされていることを要求していない。

Meridian Medical Systems LLC （2013年7月3日）

バリデーション・テストの欠落

医療機器製造のコンピュータ・システム設計のバリデートができていない

貴社にはMeridian DR 200シングルパネルX線システムのDHFがない。
当該システムは、ワークステーション、フラット・パネル検出器、認知ソフトウエア及びX線ハードウエアからなる。
DHFに不足するエレメントには以下が含まれる。
・プロジェクトの設計計画
・確立されあるいは承認されたシステムの設計インプット／アウトプット
・システムのベリフィケーションあるいはバリデーション・テスト
・設計移行
・システムのリスク・マネジメント
・設計レビュ

貴社はDHRの内容を記載するプロシージャを持たない。
加えて、レビュしたDHRファイル11本のうち11本すべてが不完全であった、ファイルの中の唯一の記録がフラット・パネル検出器荷のテストであり、X線システムの一部分に過ぎない。
DHRは以下を含んでいない；
インストレーション記録；不整合の記録；X線ハードウエア、ワークステーションまたはソフトウエア捕捉；あるいは最終製品のテスト及びシステムの品質リリースに関する記録

Fresenius Kabi Oncology Ltd （2013年7月1日）

企業はすべての電子結果を報告していない

コンピュータ・システム医療機器製造業者

…当局は査察の間に預かった何種類かのサンプル、データ及び品質を評価するローカルシステムの外部結果の実際例を観察し、文書化した。ここから貴社のカルヤニプラントにおいて生成されたデータの統合性と信頼性に関して、重大な懸念事項が持ち上がった。
例として、

a. Chromeleon and Empower IIソフトウエアをレビュしたところ、貴社はサンプルを非公式にテストしており、すべての結果を報告していないことが判明した。特に、最終QC結果として報告されるテストに先んじて、中間の「テスト」「トライアル」「デモ」注射及び最終のAPIサンプルが遂行されていた。

b.OOSあるいは望まれない結果は無視され、調査されていない。

c.サンプルは再テストされているが、再テストあるいは調査の理由となる記録がない。
合格した結果だけが有効とみなされ、米国向けデストリビューションの目的でAPIのバッチとしてリリースされていた。

d.電子データの管理において容認できない実例も留意される。
電子データの管理において、コンピュータの電子フォルダ及びファイルを容易に変更あるいは削除することができる状態が容認されていた。
貴社には、データインテグリティの欠陥を検出し、防ぐことができないため、品質システムの有効性欠如に関して、重大な懸念がある….

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