Software Validation

Entrypoint i4 follows procedures that conform to the current guidelines published by the US Food and Drug Administration in TitleĀ 21 PartĀ 11.

Summary of System Development Phases

  1. Gather the functional requirements
  2. Develop the design specifications
  3. Write and update the program
  4. Perform quality assurance testing
  5. Write and update manuals and online help
  6. Prepare for installation
  7. Perform support and maintenance functions
  8. Manage change control and configuration
  9. Perform backup and restoration, and disaster recovery
  10. Handle security

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