This section should describe the scope of the system to
be validated. It should specify the following information:
·
whether system is new or
existing
·
how the system should be or is
to be used
·
which parts of the
system/application will and will not be validated
·
justification for excluding
parts of the system
·
limitations and exclusions
·
particular application
functions
·
unused package facilities,
unused I/O ports
·
components for future use which
cannot be tested yet
·
assumptions (e.g. correct
operation, but not configuration, of operating systems or networking
software)
·
boundaries
·
physical (e.g. area of site
covered)
·
logical (e.g. interfaces
covered)
·
items to be validated (e.g.
control systems, interfaces, peripherals, instrumentation, services, other
equipment)
If the system is part of a multi-component system,
reference should be made to the Validation Protocols that will cover the
remaining components. |