Vios QMS Training: Sdlc Dop
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- 1.The Software Development Life Cycle DOP applies to both firmware and software development.
- A.
True
- B.
False
- 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.
- 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.
- 4.The SDLC DOP is only for new development, not maintenance releases.
- A.
True
- B.
False
- 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.
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