COMPUTER VALIDATION USER REQUIREMENTS

The software requirements specification document should contain a written definition of the software functions. It is not possible to validate software without predetermined and documented softwarerequirements. Typical software requirements specify the following:

1. All software system inputs;
2. All software system outputs;
3. All functions that the software system will perform;
4. All performance requirements that the software will meet, (e.g., data throughput,
   reliability, and timing);
5. The definition of all external and user interfaces, as well as any internal software-
   to-system interfaces;
6. How users will interact with the system;
7. What constitutes an error and how errors should be handled;
8. Required response times;
9. The intended operating environment for the software, if this is a design
   constraint (e.g., hardware platform, operating system);
10. All ranges, limits, defaults, and specific values that the software will accept;
11. All safety related requirements, specifications, features, or functions that will be
    implemented in software.