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Questions and Answers
What document provides a format for Vendor evaluation questionnaire?
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?
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?
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?
Which document provides a format for the Validation Report?
In which document would one find the Format for User Requirements Specification?
In which document would one find the Format for User Requirements Specification?
'ER-ES assessment verification checklist' is found in which format document?
'ER-ES assessment verification checklist' is found in which format document?
What format will be used for assigning document numbers for Validation/Qualification Documents?
What format will be used for assigning document numbers for Validation/Qualification Documents?
What size should internal qualification & validation related documents/protocols be printed on?
What size should internal qualification & validation related documents/protocols be printed on?
What should be done with pre-approved qualification protocols/documents before execution?
What should be done with pre-approved qualification protocols/documents before execution?
What should be followed if changes related to set parameters or additional tests are proposed in an existing qualified system?
What should be followed if changes related to set parameters or additional tests are proposed in an existing qualified system?
After approval, who should the executed protocol/document be handed over to?
After approval, who should the executed protocol/document be handed over to?
In case of a system/version change in an existing qualified system, what should be done?
In case of a system/version change in an existing qualified system, what should be done?
Which defect severity level allows the system to proceed to the next verification phase?
Which defect severity level allows the system to proceed to the next verification phase?
What is the recommended action for 'test script' defects with a follow-up action of 'No further action required'?
What is the recommended action for 'test script' defects with a follow-up action of 'No further action required'?
What is the recommended format for capturing and printing screenshots in hard copy format?
What is the recommended format for capturing and printing screenshots in hard copy format?
If the IT-001-F12 template is not used for screenshots, what is the mandatory requirement?
If the IT-001-F12 template is not used for screenshots, what is the mandatory requirement?
What is the purpose of a System Inventory List (SIL)?
What is the purpose of a System Inventory List (SIL)?
Who is responsible for updating the System Inventory List (SIL)?
Who is responsible for updating the System Inventory List (SIL)?
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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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