CSV SLI
Authored by Edwin Teano
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Professional Development
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10 questions
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1.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What is the main goal of Computer System Validation (CSV)?
To certify all computer systems in a company
To ensure that computer systems produce consistent, high-quality products that meet regulatory standards
To maintain only hardware systems
To eliminate human oversight in computer system operations
2.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What does "GxP" primarily refer to in CSV?
Good Programming Practice
General Pharmaceutical Practices
Good Practice guidelines for industries like manufacturing and distribution
Global Practice Standards
3.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Which of the following is NOT part of the CSV Life Cycle according to the presentation?
Planning
Coding
Verification
Operational Phase
4.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
Which model is typically used in CSV to structure validation activities?
Waterfall Model
Spiral Model
V-Model
Agile Model
5.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
According to the WHO, validation of computerized systems should be based on which approach?
Quality risk management
Cost-effectiveness
Speed of implementation
User satisfaction
6.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What is the role of audit trails in CSV?
To provide sequential access to software
To track and record changes made in a system for regulatory and compliance purposes
To prevent unauthorized users from logging in
To verify the operational speed of systems
7.
MULTIPLE CHOICE QUESTION
30 sec • 1 pt
What is the primary focus of the GAMP® guidelines?
o create a standardized certification
To define good practices for the management of computerized systems in regulated activities
To control data storage space
To create custom software solutions
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