Vios QMS Training: SDLC DOP

1.

The Software Development Life Cycle DOP applies to both firmware and software development.

A.

True
B.

False

Correct Answer
A. True

Explanation
The Software Development Life Cycle (SDLC) DOP, which stands for Development, Operations, and Production, is applicable to both firmware and software development. This means that the SDLC process, which involves planning, designing, coding, testing, and maintenance, is followed for both firmware (the software embedded in hardware devices) and software (standalone programs). By applying the SDLC DOP, organizations ensure that both firmware and software are developed and managed in a systematic and efficient manner, resulting in high-quality products.

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2.

Which options satisfy the Software Development Plan requirement? (Check all that apply.)

A.

A separate Software Development Plan or Firmware Development Plan.
B.

A Project Plan that contains or references the Software or Firmware Development Plan information.
C.

A sprint tracker spreadsheet that contains all of the work.
D.

None of the above.

Correct Answer(s)
A. A separate Software Development Plan or Firmware Development Plan.
B. A Project Plan that contains or references the Software or Firmware Development Plan information.

Explanation
The correct options that satisfy the Software Development Plan requirement are a separate Software Development Plan or Firmware Development Plan, and a Project Plan that contains or references the Software or Firmware Development Plan information. These options ensure that there is a dedicated plan specifically for software development or firmware development, and that the project plan includes or refers to the necessary information from the Software or Firmware Development Plan. This helps in ensuring proper planning and execution of the software or firmware development process.

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3.

Which options would be considered SOUP? (Check all that apply.)

A.

Off the shelf libraries
B.

Development tools such as compilers or Jira
C.

Outsourced software that does not follow Vios procedure or 62304, but is controlled.
D.

Internally developed software that does not follow Vios procedure or 62304, but is controlled.
E.

None of the above.

Correct Answer(s)
A. Off the shelf libraries
B. Development tools such as compilers or Jira
C. Outsourced software that does not follow Vios procedure or 62304, but is controlled.
D. Internally developed software that does not follow Vios procedure or 62304, but is controlled.

Explanation
The options that would be considered SOUP (Software Of Unknown Provenance) are off the shelf libraries, development tools such as compilers or Jira, outsourced software that does not follow Vios procedure or 62304 but is controlled, and internally developed software that does not follow Vios procedure or 62304 but is controlled. These options are considered SOUP because they are either pre-existing software components or software developed externally that may not have undergone the necessary validation and verification processes required by Vios procedure or 62304, but are still controlled.

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4.

The SDLC DOP is only for new development, not maintenance releases.

A.

True
B.

False

Correct Answer
B. False

Explanation
The given statement is false. The SDLC DOP (Software Development Life Cycle Definition of Process) is not only for new development but also includes maintenance releases. The SDLC DOP provides a framework for managing the entire software development process, which includes both the initial development of software as well as subsequent maintenance and updates. Therefore, the statement that the SDLC DOP is only for new development is incorrect.

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5.

What is the difference between design verification and design validation?

A.

Nothing, the terms are interchangeable.
B.

Design verification is for happy path testing and design validation is for robustness testing.
C.

Design verification assesses requirements and design validation assesses intended use.
D.

None of the above.

Correct Answer
C. Design verification assesses requirements and design validation assesses intended use.

Explanation
Design verification and design validation are two distinct processes in the product development lifecycle. Design verification is focused on testing the product design against specified requirements to ensure that it meets all the necessary criteria. This involves checking if the design meets the technical specifications, standards, and regulations.

On the other hand, design validation is concerned with evaluating the product's performance and suitability for its intended use. It involves testing the product in real-life scenarios to ensure that it functions as expected and meets the needs of the end-users.

Therefore, the correct answer is that design verification assesses requirements, while design validation assesses intended use.

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Vios QMS Training: SDLC Dop

The Software Development Life Cycle DOP applies to both firmware and software development.

Which options satisfy the Software Development Plan requirement? (Check all that apply.)

Which options would be considered SOUP? (Check all that apply.)

The SDLC DOP is only for new development, not maintenance releases.

What is the difference between design verification and design validation?