Enhancing Workflows and Compliance

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

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)

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)

<p>Using white out to correct mistakes</p> Signup and view all the answers

<p>To evaluate and select suppliers based on quality requirements</p> Signup and view all the answers

<p>To avoid mix-ups</p> Signup and view all the answers

<p>Re-validate before implementation</p> Signup and view all the answers