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?

IT-001-F16 Signup and view all the answers

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

IT-001-F03 Signup and view all the answers

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

IT-001-F11 Signup and view all the answers

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

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

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

A4 size Signup and view all the answers

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

Use them for execution 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?

Perform necessary qualifications with protocol amendment Signup and view all the answers

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

QA department Signup and view all the answers

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

Perform necessary qualifications with document revision Signup and view all the answers

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

Low 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'?

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

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

IT-001-F12 template Signup and view all the answers

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

Sign and date each screenshot by the tester Signup and view all the answers

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

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

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

The system owner department team members 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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Description

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