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pharmaceutical · data quality · process improvement

Drug Filing Data Entry Error Fishbone

種類 特性要因図規格 Ishikawa (1968) cause-and-effectエンジン schematex-fishbone更新日 2026/6/26
Drug Filing Data Entry Error Fishbone
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依頼内容

“Create a fishbone diagram for data-entry errors in a new drug registration using personnel, procedure, software, data, and regulatory categories.”

次はこちらAdd missing validation rules under Software.Change the effect to duplicate registration records.
この図に含まれるもの

図の背後にある意思決定を読み解く。

01

Structured fishbone to categorize causes

02

Focus on process and human factors

When investigating quality issues in regulatory submissions.

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