Amazing Validation Crossword Puzzle - Quality Kaizen Week 2019

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Across
  1. 4. Type of records having combination of data represented in digital form that is created, modified, maintained, archived, retrieved, or distributed electronically.
  2. 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.
  3. 7. The ________ categories which are used to determine the complexity of a software – GAMP.
  4. 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.
  5. 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. 1. Electronic Records and Electronic ________ – ERES
  2. 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. 3. GxP Spreadsheet - Spreadsheets use in creating, processing or maintaining GxP ________. The spreadsheet must be validated for use.
  4. 5. Changing validated systems requires ________ Control to ensure that there are no unexpected or unrecorded changes to the system.
  5. 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.