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  • Data Ingegrity For MFG

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    zoe
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    Data Integrity Issues

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    Data ingegrity for Mfg

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    Data Integrity Issues

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    3 views1 page

    Data Ingegrity For MFG

    Uploaded by

    zoe
    Data Integrity Issues

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    製造產線常見數據完整性问题

    Data Integrity Issues


    FDA檢查發現事實 FDA Observed Facts:

    未及時記錄 Not recording activities contemporaneously

    倒簽日期 Backdating

    沒有原始記錄或記錄造假 No raw data and/or fabricating data

    複製歷史資料作為新資料 Copying existing data as new data

    重複進樣和預檢測 Re-running samples and pre-testing

    丟棄資料（無效資料未說明)

    Discarding data (invalid data without justification)

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