生データにおけるプライマリな記録とバックアップ記録について

プライマリな記録とは、複数の方法でデータが同時に収集されまたは保管されており、それらが不整合となった場合に優先とする記録のことである。
例えば、電子温湿度管理モニタリングシステムを導入している場合、万が一の故障に備えて、バックアップ用に記録紙に記録する温湿度記録計を設置しているとしよう。
この場合、電子温湿度管理モニタリングシステムがプライマリの記録とするのが通常である。
データインテグリティの規制要件では、このように同じデータが複数のシステムにより同時に記録されている場合、データ不整合に備え、どのシステムがプライマリな記録を生成し保管しているかあらかじめ決めておかなければならない。
プライマリな記録の属性はSOPにおいて規定し、ケースバイケースで変更してはならない。
リスクマネジメント原則を使用し、プライマリな記録として指定したデータが最大の正確性、完全性、内容および意味を確実に持つようにしなければならない。
例えば、高分解能なデータまたは電子による動的なデータではなく、低分解能なデータまたは印刷や手動による静的データをプライマリな記録に指定するのは好ましくない。ただし、規格外結果などのデータ異常をリスクベースで調査する場合、プラ イマリな記録のみではなく、バックアップ記録も含めてすべてのデータを精査しなければならない。

データインテグリティに関する規程・手順書

イーコンプレスでは「データインテグリティ規程・手順書」のひな形の販売を開始いたしました。

データインテグリティ規程・手順書  55,000円(税込)

【目次】
データインテグリティ規程

1. 目的
2. 適用範囲
3. 用語の定義
4. 背景
5. データインテグリティの原則
6. データガバナンス
6.1 データインテグリティのためのステップ
6.1.1 教育およびコミュニケーション
6.1.2 リスクの発見および低減
6.1.3 技術およびITシステム
6.1.4 データガバナンス
7. 手順書等
8. 参考
9. 付則


データインテグリティ手順書

1. 目的 
2. 適用範囲 
3. 用語の定義 
4. 役割と責任 
5. 啓発活動 
6. 教育訓練 
7. 関連する手順書の改訂 
 7.1 リスクマネジメント 
   7.1.1 リスクの検討 
   7.1.2 リスク低減策の検討 
   7.1.3 リスク低減策の実施 
 7.2 データライフサイクル 
   7.2.1 データの作成 
   7.2.2 データの処理 
   7.2.3 データのレビュ・報告・使用 
   7.2.4 データの保管・維持 
8. コンピュータシステムの見直し、導入 
9. 監視・測定 
10. 監視・測定 
11. 記録の保管 
12. 参考 
13. 付則 


ご購入は こちら

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