GAMP 5

In determining “fit for use,” attention should be focused on “those aspects that are critical to patient safety, product quality, and data integrity.”

• True
• False

The key concepts to GAMP 5, 

• Lifecycle approach within QMS. 
• Scalable Lifecycle Activities. 
• Leveraging Supplier Involvement.
• All of the above

One of the interior principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process.

• False
• True

GAMP® 5 recognizes five levels of hardware

• True
• False

GAMP^® 5 is a prescriptive method 

• False
• True

The key objectives of GAMP^® 5 are Patient safety, Product quality and ____________

• CQA
• QbD
• Data Integrity
• All of the above

The end-result should be not just be an auditable set of documents, but hopefully a computer system that does what it is meant to do!

• False
• True

The validation of a computerised system to achieve and maintain GxP compliance and not necessarily throughout the lifecycle of that system

• True
• False

Understanding the difference between configuration and customization is the key to managing software and validation risk.

• True
• False

Virtual software solutions such as VMware are not necessarily to be validated since they control the operation of platform components

• True
• False