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What is the purpose of the procedure mentioned in the text?
What is the purpose of the procedure mentioned in the text?
- To provide validation for existing software only
- To evaluate the probability of occurrence of harm in software development
- To determine, describe, and document the risk of software development (correct)
- To regulate the software development process
Who does the mentioned procedure apply to?
Who does the mentioned procedure apply to?
- Only the Information Technology department
- Various departments within the company (correct)
- External regulatory bodies
- Only the Quality Assurance department
What is the definition of 'Risk' according to the text?
What is the definition of 'Risk' according to the text?
- The likelihood a negative effect will occur
- The combination of probability of occurrence of harm and the severity of that harm (correct)
- The likelihood of success in software development
- The potential financial loss due to software development
When is the mentioned procedure required within the regulated environment?
When is the mentioned procedure required within the regulated environment?
What is the scope of the mentioned procedure?
What is the scope of the mentioned procedure?
This procedure is not required within the regulated environment to evaluate software development for new or existing software which has not been validated.
This procedure is not required within the regulated environment to evaluate software development for new or existing software which has not been validated.
The procedure may be used for systems falling outside the regulated environment at the discretion of the local COOK Company’s Information Technology (IT) department.
The procedure may be used for systems falling outside the regulated environment at the discretion of the local COOK Company’s Information Technology (IT) department.
The likelihood a negative effect will occur is the definition of Severity according to the text.
The likelihood a negative effect will occur is the definition of Severity according to the text.
The combination of the probability of occurrence of harm and the severity of that harm is the definition of Risk according to the text.
The combination of the probability of occurrence of harm and the severity of that harm is the definition of Risk according to the text.
The text mentions a document titled 'Document Naming Structure' with reference D00059595(QSI0502).
The text mentions a document titled 'Document Naming Structure' with reference D00059595(QSI0502).
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