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What is the purpose of design controls?
What is the purpose of design controls?
- To improve the design of products
- To challenge established processes and procedures
- To ensure compliance with FDA regulations (correct)
- To increase efficiency and decrease time to market
What is the recommended approach for improving processes according to the text?
What is the recommended approach for improving processes according to the text?
- Use the blue book to identify requirements for your area of responsibility
- Change processes that are overly burdensome
- Challenge established processes and procedures
- Compare, review, and discuss improvement opportunities with your department and QA (correct)
What should be done during the design transfer phase according to the text?
What should be done during the design transfer phase according to the text?
- Collect all the design documents for each type of device
- Verify that the design outputs meet the design input requirements
- Perform validation under defined operating conditions on initial production lots
- Ensure the design is correctly translated into production specifications (correct)
Which of the following is NOT a good documentation practice?
Which of the following is NOT a good documentation practice?
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What is the purpose of purchasing controls?
What is the purpose of purchasing controls?
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Why is it important to identify and trace products during all stages?
Why is it important to identify and trace products during all stages?
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What should be done when there are changes in the production process?
What should be done when there are changes in the production process?
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