Validation

5. The Validation _______ Assessment is used to determine if a system is in or out of scope for validation
9. _______ is the new system being used to capture validation documentation and facilitate the validation processes
10. Electronic Records/Electronic Signatures
11. Inaccurate or misleading labelling is considered _______
13. The act of pulling a product from the market
14. _______ Specifications describe how a system performs the requirements
15. The _______ matrix ties the requirement to the design/configuration and the protocol or summary testing evidence to the requirement
16. _______ are details regarding what functionality the system needs to perform

1. The Validation _______ defines the validation strategy and required validation deliverables
2. Validation _______ are used to outline test steps and capture evidence that the system functions as expected
3. Attributable, Legible, Contemporaneous, Original and Accurate
4. _______ is used in the risk assessment process to determine how obvious it would be if a requirement were not being met by the system
6. Using unauthorized substances or incorrect ingredients, is considered _______
7. _______ is used in the risk assessment process to determine how probable it would be for a requirement to fail based on how the requirement is being met (out of the box functionality, configured or customized)
8. _______ Specifications describe in detail how a system/function will be configured
12. The _______ Report summarizes the testing performed for the validation activity