Category 4 is Configurable Software Packages. These are
called custom configurable packages in the USA.
Examples: Distributed Control Systems (DCS),
Supervisory Control and Data Acquisition packages (SCADA), manufacturing
execution systems and some LIMS and MRP packages, database and document
management applications.
(Note: In these examples the system and platform should
be well known and mature before being considered in category 4, otherwise
category 5 should apply.)
A typical feature of these systems is that they permit
users to develop their own applications by configuring/amending predefined
software modules and also developing new application software modules. Each
application (of the standard product) is therefore specific to the customer
process and maintenance becomes a key issue, particularly when new versions
of the standard product are produced.
This guide should be used to specify, design, test and
maintain the application. Particular attention should be paid to any
additional or amended code and to the configuration of the standard modules.
A software review of the modified code (including any algorithms in the
configuration) should be undertaken.
In addition, an audit of the supplier is required to
determine the level of quality and structural testing built into the
standard product. The audit needs to consider the development of the
standard product which may have followed a prototyping methodology without a
customer being involved. |