The structured design and testing of application software is an import
ant element of GMP compliance. Because application software is custom-
developed, one cannot rely on 'market hardness' as an indicator of sof
tware quality. Structured design provides a means for understanding co
mplex problems and evaluating system requirements. Communication among
users, designers and implementers is facilitated. Valuable and usable
documentation is produced. There are many existing CASE tools which c
an assist in the structured design approach. The many benefits of stru
ctured programming toward the end of validation are discussed within t
his paper.