Across
- 4. Type of records having combination of data represented in digital form that is created, modified, maintained, archived, retrieved, or distributed electronically.
- 6. All qualified equipment and validated procedures, systems and processes must undergo re-evaluation shall be conducted at least every ________ years and must be completed maximum of 3 months after the scheduled date.
- 7. The ________ categories which are used to determine the complexity of a software – GAMP.
- 8. Testing designed to challenge the system’s ability not to do what it should not according to specifications. This is important in validation execution.
- 9. Nonconformance record needs to be created to ________ the use of unvalidated GxP system (computer system, equipment, process, or method) in a GxP process.
Down
- 1. Electronic Records and Electronic ________ – ERES
- 2. It is required when your system (computer system, equipment, process, or method) is used in a GxP process or used to make decisions about the quality of the product.
- 3. GxP Spreadsheet - Spreadsheets use in creating, processing or maintaining GxP ________. The spreadsheet must be validated for use.
- 5. Changing validated systems requires ________ Control to ensure that there are no unexpected or unrecorded changes to the system.
- 10. As per 21CFR Part 11, the ________ computerized system must be managed according to a controlled life cycle which that covers change control, configuration management, and incident/problem management.