Software Validation
Entrypoint Plus follows procedures that conform to the current guidelines published by the US Food and Drug Administration in Title 21 Part 11.
Summary of System Development Phases
- Gather the functional requirements
- Develop the design specifications
- Write and update the program
- Perform quality assurance testing
- Write and update manuals and online help
- Prepare for installation
- Perform support and maintenance functions
- Manage change control and configuration
- Perform backup and restoration, and disaster recovery
- Handle security
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