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    Risk Assessment Example For CSV - EDMS

    Uploaded by

    venki_bee
    This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    Risk Assessment Example For CSV - EDMS

    Uploaded by

    venki_bee
    1K views2 pages
    This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

    Original Description:

    An example of risk assesment for EDMS - CSV.

    Original Title

    Risk Assessment Example for CSV - EDMS

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    © Attribution Non-Commercial (BY-NC)

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    This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views2 pages

    Risk Assessment Example For CSV - EDMS

    Uploaded by

    venki_bee
    This risk assessment form evaluates risks associated with electronically approving documents in a GxP environment. It identifies four main risk scenarios for displaying a document to approve: the wrong, corrupted, or incorrect version being displayed, or an unauthorized approver accepting the document. It also outlines three risk scenarios for applying an electronic signature to approve a document: the incorrect approver details, signature meaning, or time/date being recorded, or a rejected document flagged as approved. For each risk scenario, it rates the probability and severity of occurrence, and lists potential measures to mitigate the risks, such as system testing, user training, and design reviews.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    WORKED EXAMPLE

    Risk Assessment Form


    Fixemol Facility EDMS

    Example only - Not all-inclusive


    Project Number

    Project Title / Risk Assessment Overview

    FXM-123

    Assessment Scope / Assumptions Made See relevant CS Validation Plan. Function Subfunction Assessment of Risk Probability Severity Measures Class Detect. Priority

    Relevance (GxP / Business)


    GxP GxP GxP

    Risk Scenarios

    Document Approval

    Display document to approve

    Wrong document displayed Corrupted document Incorrect version displayed Approver not authorized, but accepted: system bug wrongly configured fraud Approver authorized, but not accepted bug configuration Operation seems successful but approval applied to incorrect document incorrect document incorrect version

    M L M

    H H H

    One Three One

    M H L

    H L H

    Specific testing. User SOP Acceptable Testing. User SOP

    Apply electronic signature to approve

    GxP

    L M L

    H H H

    Three One Three

    L L L

    M H M

    System test Config test. Config SOP including verification Training and security policy

    GxP

    L M

    L L

    Three Three

    H H

    L L

    Acceptable Acceptable

    GxP

    L L

    H H

    Three Three

    L L

    M M

    Design review of logic. System test Design review of logic. System test

    Risk Assessment Approved by:

    Page 1 of 2

    WORKED EXAMPLE

    Risk Assessment Form


    Fixemol Facility EDMS

    Example only - Not all-inclusive


    Project Number

    Project Title / Risk Assessment Overview

    FXM-123

    Assessment Scope / Assumptions Made See relevant CS Validation Plan.

    Function

    Subfunction

    Relevance (GxP / Business)


    GxP

    Risk Scenarios

    Assessment of Risk Probability Severity

    Measures Class Detect. Priority

    Apply electronic signature to approve

    Incorrect approver details recorded Incorrect signature meaning recorded Time/date details incorrect Rejected document is flagged as approved

    GxP GxP Reject document if approved GxP

    Risk Assessment Approved by:

    Page 2 of 2

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