IT-001 Formats Quiz
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Questions and Answers

What document provides a format for Vendor evaluation questionnaire?

  • IT-001-F01
  • IT-001-F03 (correct)
  • IT-001-F05
  • IT-001-F07
  • Which document includes the format for System Configuration & design Specification?

  • IT-001-F12
  • IT-001-F10
  • IT-001-F08 (correct)
  • IT-001-F06
  • Where can you find the format for Code Review Report?

  • IT-001-F13
  • IT-001-F11
  • IT-001-F09 (correct)
  • IT-001-F15
  • Which document provides a format for the Validation Report?

    <p>IT-001-F16</p> Signup and view all the answers

    In which document would one find the Format for User Requirements Specification?

    <p>IT-001-F03</p> Signup and view all the answers

    'ER-ES assessment verification checklist' is found in which format document?

    <p>IT-001-F11</p> Signup and view all the answers

    What format will be used for assigning document numbers for Validation/Qualification Documents?

    <p>&lt;Site ID / Company ID&gt;&lt; Area Name&gt;-&lt;System ID&gt; &lt;Document Type Document serial no., if required&gt;-&lt;Document version number&gt;</p> Signup and view all the answers

    What size should internal qualification & validation related documents/protocols be printed on?

    <p>A4 size</p> Signup and view all the answers

    What should be done with pre-approved qualification protocols/documents before execution?

    <p>Use them for execution</p> Signup and view all the answers

    What should be followed if changes related to set parameters or additional tests are proposed in an existing qualified system?

    <p>Perform necessary qualifications with protocol amendment</p> Signup and view all the answers

    After approval, who should the executed protocol/document be handed over to?

    <p>QA department</p> Signup and view all the answers

    In case of a system/version change in an existing qualified system, what should be done?

    <p>Perform necessary qualifications with document revision</p> Signup and view all the answers

    Which defect severity level allows the system to proceed to the next verification phase?

    <p>Low</p> Signup and view all the answers

    What is the recommended action for 'test script' defects with a follow-up action of 'No further action required'?

    <p>Pre-approval of the defect is required, but no post-approval</p> Signup and view all the answers

    What is the recommended format for capturing and printing screenshots in hard copy format?

    <p>IT-001-F12 template</p> Signup and view all the answers

    If the IT-001-F12 template is not used for screenshots, what is the mandatory requirement?

    <p>Sign and date each screenshot by the tester</p> Signup and view all the answers

    What is the purpose of a System Inventory List (SIL)?

    <p>To serve as a one-stop resource for system information</p> Signup and view all the answers

    Who is responsible for updating the System Inventory List (SIL)?

    <p>The system owner department team members</p> Signup and view all the answers

    Study Notes

    Document Numbering Log

    • Document numbering format: - -
    • Request document numbering through the "Document Numbering Log" format manually
    • Respective users shall request document numbering

    Qualification and Validation Documents

    • Pre-approved protocols/documents shall be used for execution
    • Post-approval of executed protocol/document shall be handed over to QA-department
    • Changes to set parameters require additional tests and qualification with respective documents as protocol amendment
    • System changes require qualification with respective documents revision (as applicable)
    • New/existing system changes require following site/company change control procedure

    Formats

    • IT-001-F01: Qualification Flow chart
    • IT-001-F02: Inventory of GxP Computerized Systems
    • IT-001-F03: Format for User Requirements Specification
    • ... (up to IT-001-F20: Format for Document Numbering Log)

    History of Changes

    • Version 00: Initial Version (25/03/2022)
    • Version 01: History of changes incorporated in Section 9.0 (26/05/2023)
    • Version 02: Cloud Application validation procedure incorporated in Section 6.0 (Approval date)

    Defect Classification

    • Critical: System cannot proceed for next phase of verification with this type of defect in ‘Open’ state
    • Medium: Incorrect functionality of component or process that does not affect other functions
    • Low: Spelling/Typo errors, User Interface not proper or inconsistent, etc.

    System Inventory List (SIL)

    • A one-stop resource for discovering information about the system
    • Updated by respective system owner department team members for all qualified systems as per IT-001-F02

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    Test your knowledge on various formats related to IT-001 such as Qualification Flow chart, User Requirements Specification, Vendor Evaluation Questionnaire, and more.

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